(35 days)
2, 4a,b, 5, 6c, 7, 8, 9, 10, 11, 12
Pye Unicam SP 1200,Varian Gemini 200,Finnigan SSQ 7000
No
The provided text describes a physical medical device (detachable coil and syringe) used for embolization and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for embolizing intracranial aneurysms and other vascular malformations, which involves active treatment to close off blood flow to address medical conditions.
No
The device is an embolic coil used for treating aneurysms and vascular malformations, not for diagnosing them. Its intended use is for embolizing, which is a therapeutic intervention, not a diagnostic process.
No
The device description and intended use clearly describe a physical medical device (detachable coil and syringe) used for embolization, not a software-only product.
Based on the provided information, the TRUFILL® DCS Detachable Coil and Syringe are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used for embolization within the body (intracranial and peripheral vasculature). This is a therapeutic procedure performed directly on the patient.
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. They are used in vitro (outside the body).
The TRUFILL® DCS system is an implantable medical device used for a surgical/interventional procedure, not for analyzing biological samples.
N/A
Int. J. Electrochem. Sci., 7 (2012) 166 - 175
International Journal
of
Electrochemical
Science
www.electrochem.org
Synthesis of Some Pyrazoline, Pyrrolidine and Pyrrolizine Derivatives Incorporating Pyrimidine Moiety
Mohamed A.M. El-hashash *, Abdellfattah H. Salem and Tarek H.A. Elmaaty
Chemistry Department, Faculty of Science, Ain Shams University, Cairo, Egypt
- E-mail: m_elhashash@yahoo.com
Received: 10 October 2011 / Accepted: 15 November 2011 / Published: 1 January 2012
Some new pyrazolines, pyrrolidine and pyrrolizine derivatives were synthesized. Thus, 1-(3-chloro-
4,5-dihydro-1H-pyrazol-5-yl)ethanone 2 was condensed with 4-amino-6-hydrazinopyrimidine and
heteroaromatic hydrazine derivatives to give the corresponding hydrazone and pyrazoline
derivatives 4a,b, 5 and 6c respectively. Also, the reaction of compound 2 with amines and active
methylene derivatives afforded the Mannich base 7 and pyrimidine 8 respectively. Furthermore,
treatment of 2 with ethyl 2-cyanoacetate yielded cyclized product 9. Moreover, the reaction of
ethyl 2-((4-(dimethylamino)phenyl)methylene)-3-oxobutanoate 10 with 4-amino-6-
aminopyrimidine and amines gave pyrrolidine 11 and pyrrolizine 12 derivatives respectively. The
structure of the target molecules were confirmed by elemental analysis and spectral data.
Keywords: 1-(3-chloro-4,5-dihydro-1H-pyrazol-5-yl)ethanone, pyrazolines, pyrrolidine,
pyrrolizine, pyrimidine.
- INTRODUCTION
Pyrimidine is a six-membered heterocyclic aromatic ring containing two nitrogen atoms
in positions 1 and 3. Pyrimidine is the parent compound of pyrimidine bases such as cytosine,
thymine and uracil, which are important constituents of nucleic acids [1-3]. Pyrimidine derivatives
display a wide variety of pharmacological and biological activities such as antitumor [4,5],
antiproliferative [6,7], antibacterial [8], antiviral [9], anti-inflammatory [10], antimalarial [11],
antifungal [12], analgesic [13], anti-HIV [14] and antioxidant [15] agents. This prompts us to
synthesize new pyrazoline, pyrrolidine and pyrrolizine derivatives incorporating pyrimidine
moiety as promising compounds for biological activity research.
- EXPERIMENTAL
2.1. General
Melting points were determined on a Gallenkamp melting point apparatus and are
uncorrected. IR spectra were recorded on a Pye Unicam SP 1200 spectrophotometer using KBr
disc. 1H-NMR spectra were recorded on a Varian Gemini 200 (200 MHZ) with TMS as internal
standard. Mass spectra were recorded on a Finnigan SSQ 7000 spectrometer. Elemental analyses
were carried out at the Microanalytical Center, Cairo University, Egypt.
2.2. Synthesis of 1-(3-chloro-4,5-dihydro-1H-pyrazol-5-yl)ethanone (2)
To a solution of 1-chloro-3-buten-2-one (1 mol) in absolute ethanol (50 mL) was added
dropwise hydrazine hydrate (1.0 mol) in absolute ethanol (20 mL) at 0 °C. The mixture was
stirred for 30 min at 0 °C then refluxed for 2 h. The solvent was evaporated under vacuum and the
residue was crystallized from ethanol to give compound 2.
Yield 75%; mp 110-112 °C; IR (KBr): v = 3280, 3180 (NH, NH), 1670 (C=O) cm-1; 1H-
NMR (DMSO-d6): delta = 2.1 (s, 3H, CH3), 2.8 (dd, 1H, CH), 3.0 (dd, 1H, CH), 4.7 (dd, 1H, CH),
7.1 (s, 1H, NH), 8.5 (s, 1H, NH) ppm; MS: m/z (%) = 146 (M+, 70), 148 (M+2, 30); Anal.
Calcd for C5H7ClN2O: C, 41.09; H, 4.83; N, 19.17. Found: C, 40.95; H, 4.77; N, 19.04.
2.3. Synthesis of (E)-ethanone hydrazone 4a and (E)-N'-(3-chloro-4,5-dihydro-1H-pyrazol-5-
yl)ethanone hydrazone 4b
A mixture of compound 2 (1 mmol) and 4-amino-6-hydrazinopyrimidine (1 mmol) in
absolute ethanol (20 mL) was refluxed for 5 h. The solvent was evaporated under vacuum and the
residue was crystallized from ethanol to give compound 4a.
Yield 80%; mp 170-172 °C; IR (KBr): v = 3450, 3350, 3280, 3180 (NH, NH2), 1640
(C=N of pyrimidine) cm-1; 1H-NMR (DMSO-d6): delta = 2.1 (s, 3H, CH3), 2.8 (dd, 1H, CH), 3.0
(dd, 1H, CH), 4.7 (dd, 1H, CH), 5.7 (s, 2H, NH2), 7.1 (s, 1H, NH), 8.5 (s, 1H, NH), 8.8 (s, 1H,
pyrimidine-H) ppm; MS: m/z (%) = 258 (M+, 100), 260 (M+2, 40); Anal. Calcd for C9H12ClN7:
C, 41.94; H, 4.69; N, 38.00. Found: C, 41.88; H, 4.75; N, 37.92.
Compound 4b was prepared according to the same procedure for compound 4a using 2-
hydrazinobenzothiazole instead 4-amino-6-hydrazinopyrimidine.
3
Yield 70%; mp 150-152 °C; IR (KBr): v = 3280, 3180, 3120 (NH), 1660 (C=N) cm-1; 1H-
NMR (DMSO-d6): delta = 2.1 (s, 3H, CH3), 2.8 (dd, 1H, CH), 3.0 (dd, 1H, CH), 4.7 (dd, 1H, CH),
7.1 (s, 1H, NH), 7.3-7.8 (m, 4H, Ar-H), 8.5 (s, 1H, NH) ppm; MS: m/z (%) = 300 (M+, 100), 302
(M+2, 40); Anal. Calcd for C12H13ClN4S: C, 47.92; H, 4.36; N, 18.66. Found: C, 47.85; H, 4.29;
N, 18.57.
2.4. Synthesis of 1-((3-chloro-4,5-dihydro-1H-pyrazol-5-yl)ethanone)thiosemicarbazone (5)
To a solution of compound 2 (1 mmol) in absolute ethanol (20 mL) was added
thiosemicarbazide (1 mmol). The mixture was refluxed for 3 h. The solvent was evaporated
under vacuum and the residue was crystallized from ethanol to give compound 5.
Yield 70%; mp 140-142; IR (KBr): v = 3450, 3350, 3280, 3180 (NH, NH2), 1640
(C=N), 1250 (C=S) cm-1; 1H-NMR (DMSO-d6): delta = 2.1 (s, 3H, CH3), 2.8 (dd, 1H, CH), 3.0
(dd, 1H, CH), 4.7 (dd, 1H, CH), 7.1 (s, 1H, NH), 7.5 (s, 2H, NH2), 8.5 (s, 1H, NH), 9.0 (s, 1H,
NH) ppm; MS: m/z (%) = 217 (M+, 70), 219 (M+2, 30); Anal. Calcd for C6H10ClN3OS: C, 33.14;
H, 4.64; N, 19.33. Found: C, 33.02; H, 4.58; N, 19.25.
2.5. Synthesis of 1-acetyl-5-(3-chloro-4,5-dihydro-1H-pyrazol-5-yl)-3-methyl-1H-pyrazole
(6c)
A mixture of compound 2 (1 mmol) and acetylacetone (1 mmol) in absolute ethanol (20
mL) was refluxed for 5 h. The solvent was evaporated under vacuum and the residue was
crystallized from ethanol to give compound 6c.
Yield 70%; mp 130-132 °C; IR (KBr): v = 3280, 3180 (NH), 1670 (C=O), 1640 (C=N)
cm-1; 1H-NMR (DMSO-d6): delta = 2.1 (s, 3H, CH3), 2.3 (s, 3H, CH3), 2.6 (s, 3H, CH3), 2.8 (dd,
1H, CH), 3.0 (dd, 1H, CH), 4.7 (dd, 1H, CH), 6.5 (s, 1H, CH), 7.1 (s, 1H, NH), 8.5 (s, 1H, NH)
ppm; MS: m/z (%) = 246 (M+, 70), 248 (M+2, 30); Anal. Calcd for C10H13ClN2O2: C, 48.69; H,
5.31; N, 11.36. Found: C, 48.58; H, 5.25; N, 11.28.
2.6. Synthesis of 1-(3-chloro-4,5-dihydro-1H-pyrazol-5-yl)-2-(piperidin-1-yl)ethanone (7)
To a solution of compound 2 (1 mmol) in absolute ethanol (20 mL) was added
formaldehyde (1 mmol) and piperidine (1 mmol). The mixture was stirred for 3 h at room
temperature. The solvent was evaporated under vacuum and the residue was crystallized from
ethanol to give compound 7.
Yield 70%; mp 120-122 °C; IR (KBr): v = 3280, 3180 (NH), 1670 (C=O) cm-1; 1H-
NMR (DMSO-d6): delta = 1.5 (m, 6H, 3CH2), 2.1 (s, 3H, CH3), 2.4 (m, 4H, 2CH2), 2.8 (dd, 1H,
CH), 3.0 (dd, 1H, CH), 4.7 (dd, 1H, CH), 7.1 (s, 1H, NH), 8.5 (s, 1H, NH) ppm; MS: m/z (%) =
246 (M+, 100), 248 (M+2, 40); Anal. Calcd for C11H18ClN3O: C, 53.75; H, 7.38; N, 17.11. Found:
C, 53.68; H, 7.32; N, 17.02.
2.7. Synthesis of 4-(3-chloro-4,5-dihydro-1H-pyrazol-5-yl)-6-methylpyrimidine-2-thiol (8)
A mixture of compound 2 (1 mmol) and thiourea (1 mmol) in absolute ethanol (20 mL)
was refluxed for 5 h. The solvent was evaporated under vacuum and the residue was crystallized
from ethanol to give compound 8.
Yield 70%; mp 160-162 °C; IR (KBr): v = 3280, 3180 (NH), 2550 (SH), 1640 (C=N) cm-
1; 1H-NMR (DMSO-d6): delta = 2.1 (s, 3H, CH3), 2.8 (dd, 1H, CH), 3.0 (dd, 1H, CH), 4.7 (dd, 1H,
CH), 7.1 (s, 1H, NH), 8.5 (s, 1H, NH), 13.0 (s, 1H, SH) ppm; MS: m/z (%) = 230 (M+, 100), 232
(M+2, 40); Anal. Calcd for C8H9ClN4S: C, 41.65; H, 3.93; N, 24.32. Found: C, 41.58; H, 3.87; N,
24.25.
4
2.8. Synthesis of 2-amino-4-(3-chloro-4,5-dihydro-1H-pyrazol-5-yl)-6-methylnicotinonitrile (9)
A mixture of compound 2 (1 mmol) and ethyl 2-cyanoacetate (1 mmol) in absolute
ethanol (20 mL) was refluxed for 5 h. The solvent was evaporated under vacuum and the residue
was crystallized from ethanol to give compound 9.
Yield 70%; mp 180-182 °C; IR (KBr): v = 3450, 3350, 3280, 3180 (NH, NH2), 2220
(CN), 1640 (C=N) cm-1; 1H-NMR (DMSO-d6): delta = 2.1 (s, 3H, CH3), 2.8 (dd, 1H, CH), 3.0
(dd, 1H, CH), 4.7 (dd, 1H, CH), 5.7 (s, 2H, NH2), 7.1 (s, 1H, NH), 8.5 (s, 1H, NH) ppm; MS: m/z
(%) = 262 (M+, 100), 264 (M+2, 40); Anal. Calcd for C12H11ClN4O: C, 55.07; H, 4.23; N, 21.42.
Found: C, 55.00; H, 4.18; N, 21.35.
2.9. Synthesis of ethyl 2-((4-(dimethylamino)phenyl)methylene)-3-oxobutanoate (10)
A mixture of ethyl acetoacetate (1 mmol) and 4-dimethylaminobenzaldehyde (1 mmol)
in absolute ethanol (20 mL) was refluxed for 5 h. The solvent was evaporated under vacuum and
the residue was crystallized from ethanol to give compound 10.
Yield 80%; mp 130-132 °C; IR (KBr): v = 1730 (C=O ester), 1670 (C=O) cm-1; 1H-NMR
(DMSO-d6): delta = 1.3 (t, 3H, CH3), 2.3 (s, 3H, CH3), 3.0 (s, 6H, N(CH3)2), 4.2 (q, 2H, CH2), 7.3-
7.8 (m, 4H, Ar-H), 8.1 (s, 1H, CH) ppm; MS: m/z (%) = 277 (M+, 100); Anal. Calcd for
C15H19NO3: C, 65.95; H, 6.90; N, 5.05. Found: C, 65.88; H, 6.85; N, 5.00.
2.10. Synthesis of ethyl 4-(4-(dimethylamino)phenyl)-2,5-dioxo-1-(pyrimidin-4-yl)pyrrolidine-
3-carboxylate (11)
A mixture of compound 10 (1 mmol) and 4-amino-6-aminopyrimidine (1 mmol) in
absolute ethanol (20 mL) was refluxed for 5 h. The solvent was evaporated under vacuum and the
residue was crystallized from ethanol to give compound 11.
Yield 70%; mp 190-192 °C; IR (KBr): v = 3280, 1730 (C=O ester), 1670 (C=O) cm-1;
1H-NMR (DMSO-d6): delta = 1.3 (t, 3H, CH3), 2.3 (s, 3H, CH3), 3.0 (s, 6H, N(CH3)2), 4.2 (q, 2H,
CH2), 7.1 (d, 1H, pyrimidine-H), 7.3-7.8 (m, 4H, Ar-H), 8.5 (d, 1H, pyrimidine-H) ppm; MS:
m/z (%) = 394 (M+, 100); Anal. Calcd for C20H22N4O3: C, 65.17; H, 5.92; N, 14.30. Found: C,
65.10; H, 5.85; N, 14.22.
2.11. Synthesis of ethyl 4-(4-(dimethylamino)phenyl)-2,5-dioxo-1-(piperidin-1-yl)pyrrolidine-
3-carboxylate (12)
A mixture of compound 10 (1 mmol) and piperidine (1 mmol) in absolute ethanol (20
mL) was refluxed for 5 h. The solvent was evaporated under vacuum and the residue was
crystallized from ethanol to give compound 12.
Yield 70%; mp 150-152 °C; IR (KBr): v = 1730 (C=O ester), 1670 (C=O) cm-1; 1H-NMR
(DMSO-d6): delta = 1.3 (t, 3H, CH3), 1.5 (m, 6H, 3CH2), 2.3 (s, 3H, CH3), 2.4 (m, 4H, 2CH2), 3.0
(s, 6H, N(CH3)2), 4.2 (q, 2H, CH2), 7.3-7.8 (m, 4H, Ar-H) ppm; MS: m/z (%) = 387 (M+, 100);
Anal. Calcd for C22H31N3O3: C, 68.17; H, 8.01; N, 10.74. Found: C, 68.10; H, 7.95; N, 10.65.
5
- RESULTS AND DISCUSSION
The synthetic pathway for the preparation of products 4a,b, 5, 6c, 7, 8 and 9 are shown
in Scheme 1. Thus, 1-chloro-3-buten-2-one (1) was treated with hydrazine hydrate to give 1-(3-
chloro-4,5-dihydro-1H-pyrazol-5-yl)ethanone (2). The IR spectrum of 2 showed absorption bands
at 3280, 3180 (NH, NH) cm-1 and 1670 (C=O) cm-1. The 1H-NMR spectrum of 2 showed
signals at delta = 2.1 (s, 3H, CH3), 2.8 (dd, 1H, CH), 3.0 (dd, 1H, CH), 4.7 (dd, 1H, CH), 7.1 (s,
1H, NH), 8.5 (s, 1H, NH) ppm. The mass spectrum of 2 confirmed the molecular ion peak at m/z
= 146 (M+, 70) and 148 (M+2, 30). Moreover, elemental analysis data were in accordance with
the presumed structure.
The reaction of compound 2 with 4-amino-6-hydrazinopyrimidine afforded hydrazone
derivative 4a. Its IR spectrum showed absorption bands at 3450, 3350, 3280, 3180 (NH, NH2)
cm-1 and 1640 (C=N of pyrimidine) cm-1. The 1H-NMR spectrum of 4a showed signals at
delta = 2.1 (s, 3H, CH3), 2.8 (dd, 1H, CH), 3.0 (dd, 1H, CH), 4.7 (dd, 1H, CH), 5.7 (s, 2H, NH2),
7.1 (s, 1H, NH), 8.5 (s, 1H, NH), 8.8 (s, 1H, pyrimidine-H) ppm. The mass spectrum of 4a showed
the molecular ion peak at m/z = 258 (M+, 100) and 260 (M+2, 40). While, condensation of 2 with
2-hydrazinobenzothiazole gave hydrazone 4b. Also, compound 2 was treated with
thiosemicarbazide to give thiosemicarbazone derivative 5.
Furthermore, the reaction of compound 2 with active methylene derivatives was
investigated. Thus, compound 2 reacted with acetylacetone to afford pyrazoline derivative 6c. Its
IR spectrum showed absorption bands at 3280, 3180 (NH) cm-1, 1670 (C=O) cm-1 and 1640 (C=N)
cm-1. The 1H-NMR spectrum of 6c showed signals at delta = 2.1 (s, 3H, CH3), 2.3 (s, 3H, CH3),
2.6 (s, 3H, CH3), 2.8 (dd, 1H, CH), 3.0 (dd, 1H, CH), 4.7 (dd, 1H, CH), 6.5 (s, 1H, CH), 7.1 (s,
1H, NH), 8.5 (s, 1H, NH) ppm. The mass spectrum of 6c showed the molecular ion peak at m/z
= 246 (M+, 70) and 248 (M+2, 30).
On the other hand, compound 2 underwent Mannich reaction with formaldehyde and
piperidine to give Mannich base 7. Its IR spectrum showed absorption bands at 3280, 3180
(NH) cm-1 and 1670 (C=O) cm-1. The 1H-NMR spectrum of 7 showed signals at delta = 1.5 (m,
6H, 3CH2), 2.1 (s, 3H, CH3), 2.4 (m, 4H, 2CH2), 2.8 (dd, 1H, CH), 3.0 (dd, 1H, CH), 4.7 (dd, 1H,
CH), 7.1 (s, 1H, NH), 8.5 (s, 1H, NH) ppm. The mass spectrum of 7 showed the molecular ion
peak at m/z = 246 (M+, 100) and 248 (M+2, 40).
Moreover, the novel pyrimidine derivative 8 was obtained from the reaction of 2 with
thiourea. Its IR spectrum exhibited absorption bands at 3280, 3180 (NH) cm-1, 2550 (SH) cm-1
and 1640 (C=N) cm-1. The 1H-NMR spectrum of 8 showed signals at delta = 2.1 (s, 3H, CH3),
2.8 (dd, 1H, CH), 3.0 (dd, 1H, CH), 4.7 (dd, 1H, CH), 7.1 (s, 1H, NH), 8.5 (s, 1H, NH), 13.0 (s,
1H, SH) ppm. The mass spectrum of 8 showed the molecular ion peak at m/z = 230 (M+, 100)
and 232 (M+2, 40).
The cyclized product 9 was obtained from the reaction of compound 2 with ethyl 2-
cyanoacetate. Its IR spectrum showed absorption bands at 3450, 3350, 3280, 3180 (NH, NH2)
cm-1 and 2220 (CN), 1640 (C=N) cm-1. The 1H-NMR spectrum of 9 showed signals at delta =
2.1 (s, 3H, CH3), 2.8 (dd, 1H, CH), 3.0 (dd, 1H, CH), 4.7 (dd, 1H, CH), 5.7 (s, 2H, NH2), 7.1 (s,
1H, NH), 8.5 (s, 1H, NH) ppm. The mass spectrum of 9 showed the molecular ion peak at m/z
= 262 (M+, 100) and 264 (M+2, 40).
The synthetic pathway for the preparation of pyrrolidine 11 and pyrrolizine 12 derivatives
are shown in Scheme 2. Thus, ethyl acetoacetate (ethyl 3-oxobutanoate) was treated with 4-
dimethylaminobenzaldehyde in ethanolic solution to give ethyl 2-((4-
(dimethylamino)phenyl)methylene)-3-oxobutanoate (10). Its IR spectrum showed absorption
bands at 1730 (C=O ester) cm-1 and 1670 (C=O) cm-1. The 1H-NMR spectrum of 10 showed
signals at delta = 1.3 (t, 3H, CH3), 2.3 (s, 3H, CH3), 3.0 (s, 6H, N(CH3)2), 4.2 (q, 2H, CH2), 7.3-7.8
(m, 4H, Ar-H), 8.1 (s, 1H, CH) ppm. The mass spectrum of 10 showed the molecular ion peak at
m/z = 277 (M+, 100).
6
Compound 10 was treated with 4-amino-6-aminopyrimidine to afford pyrrolidine 11.
Its IR spectrum showed absorption bands at 3280, 1730 (C=O ester) cm-1 and 1670 (C=O) cm-1.
The 1H-NMR spectrum of 11 showed signals at delta = 1.3 (t, 3H, CH3), 2.3 (s, 3H, CH3), 3.0 (s,
6H, N(CH3)2), 4.2 (q, 2H, CH2), 7.1 (d, 1H, pyrimidine-H), 7.3-7.8 (m, 4H, Ar-H), 8.5 (d, 1H,
pyrimidine-H) ppm. The mass spectrum of 11 showed the molecular ion peak at m/z = 394 (M+,
100).
On the other hand, the reaction of compound 10 with piperidine afforded pyrrolizine 12.
Its IR spectrum showed absorption bands at 1730 (C=O ester) cm-1 and 1670 (C=O) cm-1. The
1H-NMR spectrum of 12 showed signals at delta = 1.3 (t, 3H, CH3), 1.5 (m, 6H, 3CH2), 2.3 (s,
3H, CH3), 2.4 (m, 4H, 2CH2), 3.0 (s, 6H, N(CH3)2), 4.2 (q, 2H, CH2), 7.3-7.8 (m, 4H, Ar-H) ppm.
The mass spectrum of 12 showed the molecular ion peak at m/z = 387 (M+, 100).
Scheme 1
Reaction of 1-chloro-3-buten-2-one (1) to give compounds 2, 4a,b, 5, 6c, 7, 8 and 9.
7
Scheme 2
Reaction of ethyl acetoacetate to give compounds 10, 11 and 12.
- CONCLUSIONS
Some new pyrazoline, pyrrolidine and pyrrolizine derivatives were synthesized. The
structures of the new compounds were confirmed by spectral and elemental analysis. All the
synthesized compounds possess a pyrimidine moiety. The new compounds could be useful as
potential candidates for biological activities.
References
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H. Kalchenko, ARKIVOC, 2 (2007) 192.
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H. A. Moussa, S. M. Abdel-Raouf, Molecules, 16 (2011) 7551.
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[4] W. Z. Hu, P. H. Luo, C. H. Zeng, X. D. Mao, Y. G. Wang, Eur. J. Med. Chem., 45 (2010)
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[7] P. J. K. U. Reddy, G. R. J. Rao, A. R. R. Rao, C. M. Reddy, M. V. R. Reddy, S. P. Prasad, RK,
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© 2012 by ESG (www.electrochem.org). All rights reserved.
8
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of a bird or eagle with its wings spread.
Public Health Service
SEP 2 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Amarilys Machado Senior Regulatory Affairs Specialist Cordis Neurovascular, Inc. 14000 N.W. 57th Court Miami Lakes. Florida 33014
Re: K032553
Trade/Device Name: TRUFILL DCS ORBIT™ Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: August 18, 2003 Received: August 25, 2003
Dear Ms. Machado:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Amarilys Machado
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Sincerely yours,
, Mark N Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K032\$\$3
Cordis Franchise Form - ( Intended Use Statement
Effective Date 11/15/00
Page 1 of 1
510(k) Number (if known):
Device Name: TRUFILL DCS ORBIT™ Detachable Coil and TRUFILL® DCS Syringe, also known as the TRUFILL DCS ORBIT™ Detachable Coil System.
Indications for Use Statement
The TRUFILL® DCS Detachable Coil is indicated for embolizing certain intracranial aneurysms that, because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be:
very high-risk for management by traditional operative techniques 1)
inoperable 2)
and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.
The TRUFILL® DCS Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature.
The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over-The-Counter Use
Mark N Millam
estorative
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