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Found 7 results
510(k) Data Aggregation
K Number
K972521Device Name
NAVIGATOR (STYLET) 2006
Manufacturer
SIL-MED CORP.
Date Cleared
1997-10-01
(86 days)
Product Code
GAH
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
SIL-MED CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Navigator (stylet) is a stainless steel wire rod, inserted into the catheter to assist with insertion and placement of the catheter in the peritoneum.
Device Description
Stainless steel wire rod intended to aid in the manipulation of or insertion of the catheter for placement in the peritoneum.
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K Number
K961392Device Name
ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II
Manufacturer
SIL-MED CORP.
Date Cleared
1997-07-18
(463 days)
Product Code
FJS
Regulation Number
876.5630Why did this record match?
Applicant Name (Manufacturer) :
SIL-MED CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Peritoneal Dialysis Coil Catheter with Spi-Argent™II, for the transport of dialysate solution to and from the peritoneal cavity for treatment of renal failure; suitable for CAPD (Continuous Ambulatory Peritoneal Dialysis)
Device Description
Peritoneal Dialysis Coil Catheter with Spi-Argent™II, for the transport of dialysate solution to and from the peritoneal cavity for treatment of renal failure; suitable for CAPD (Continuous Ambulatory Peritoneal Dialysis). Peritoneal Dialysis Coil Catheter with Spi-Argent™ll is the same as the Peritoneal Dialysis Coil Catheter, K850247 except for the Spi-Argent™ II option offering. Spi-Argent™ II is the same surface treatment as the K942709, Mediastinal Drain with Spi-Argent™ II. The Spi-Argent™II surface treatment provides a lubricious surface to ease insertion and removal of the catheter.
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K Number
K961194Device Name
ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN
Manufacturer
SIL-MED CORP.
Date Cleared
1996-08-08
(134 days)
Product Code
GBW
Regulation Number
878.4200Why did this record match?
Applicant Name (Manufacturer) :
SIL-MED CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Catheter for drainage of blood and fluid from mediastinum after chest surgery and/or trauma; for use with suction apparatus
Device Description
Silicone perforated tubing, flattened profile, blue radiopaque stripe; surface treated to reduce friction and Antimicrobial; perforations ("eyes") on both flattened surfaces of tubing; external end has cutaway adapter; imprinted with drain size
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K Number
K961295Device Name
SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR
Manufacturer
SIL-MED CORP.
Date Cleared
1996-06-26
(83 days)
Product Code
GBX
Regulation Number
878.4200Why did this record match?
Applicant Name (Manufacturer) :
SIL-MED CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For post-operative drainage of serosanguineous fluids and blood away from operative site; for use with suction reservoir as a closed wound drain system
Device Description
Two joined silicone tubing sections; flat drain section is partially perforated for fluid collection, is ribbed to prevent collapse as suction is applied, and has blue radiopaque stripe; round tubing is connected to suction reservoir inlet; offered with an introduction Trocar attached as an option; silver ion surface treated to ease insertion and removal.
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K Number
K960099Device Name
PENROSE DRAIN MODELS 6001 - 6007
Manufacturer
SIL-MED CORP.
Date Cleared
1996-03-11
(60 days)
Product Code
GCY
Regulation Number
878.4680Why did this record match?
Applicant Name (Manufacturer) :
SIL-MED CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Post-operative passive drainage of serosanguineous fluids away from soft tissue operative site.
Device Description
Passive Wound Drain. Flat Silicone Drain. Dimensionally equivalent to the Davol Gravity Drain, except Davol offers both 12" and 18"; Sil-Med Corporation offers 18" only. Both have inner diameter teeth to prevent the drain from collapsing. Both devices have a Radiopaque stripe. Sil-Med Penrose Drains are sold sterile only.
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K Number
K955463Device Name
GRIP-A-BOOTS
Manufacturer
SIL-MED CORP.
Date Cleared
1996-01-23
(55 days)
Product Code
LXZ
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
SIL-MED CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K942709Device Name
MEDIASTINAL SILICONE DRAINS
Manufacturer
SIL-MED CORP.
Date Cleared
1996-01-04
(575 days)
Product Code
GBW
Regulation Number
878.4200Why did this record match?
Applicant Name (Manufacturer) :
SIL-MED CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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