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510(k) Data Aggregation
K Number
K220981Device Name
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
Manufacturer
Fehling Surgical Instruments, Inc.
Date Cleared
2023-04-20
(381 days)
Product Code
DWP
Regulation Number
870.4475Why did this record match?
Product Code :
DWP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fehling SUPERPLAST Probes are intended to be used to enlarge or calibrate vessels during coronary artery bypass and angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
Device Description
The Fehling SUPERPLAST Probes are intended to be used to enlarge or calibrate vessels during coronary artery bypass and angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels and to perform various maneuvers of dilation and measurement of annulus and lumen diameters. The coronary probe is available in different lengths and diameters to accommodate the needs of various surgical procedures and vessel anatomies. The probe is constructed of Titanium Alloy (TiAl6V4), Nitinol, and Titanium (Grade 2). Coronary probes are supplied non-sterile.
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K Number
K183438Device Name
Geomed Vascular Dilators
Manufacturer
Geomed Medizin-Technik GmbH & Co.
Date Cleared
2019-09-03
(265 days)
Product Code
DWP
Regulation Number
870.4475Why did this record match?
Product Code :
DWP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Geomed Vascular Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
Device Description
Vascular Dilators are reusable stainless-steel surgical instruments that are used by qualified surgeons to enlarge or calibrate vessels. They are provided in two basic models and various sizes to accommodate individual needs, based on the anatomy of the site and the type of surgical procedure. The device is provided non-sterile for steam sterilization by the user.
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K Number
K163524Device Name
Vessel Dilator
Manufacturer
Fetzer Medical GmbH & Co. KG
Date Cleared
2017-06-29
(196 days)
Product Code
DWP
Regulation Number
870.4475Why did this record match?
Product Code :
DWP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fetzer Medical vessel dilators are devices used to enlarge or calibrate a vessel during cardiovascular surgery.
Device Description
Fetzer Medical Vessel Dilators are reusable manual surgical instruments. They are rod-like devices with a long, slender, solid shaft and a distal tip of various shapes and sizes. They are sold unsterile and can be reused (cleaned and sterilized) according the instructions for use.
There are several types of dilators made from stainless steel or aluminum:
- Cooley Coronary Dilators
- Cooley Vessel Dilators
- Garrett Vascular Dilators
- Hiebert Vascular Dilators
- DeBakey Vascular Dilators
- Sarns-Style Dilators
- Myocardial Dilators
These dilators are available in a range of different length and diameters.
The handle of the DeBakey Vascular Dilator, the Cooley Vessel Dilator, the Cooley Coronary Dilator, the Hiebert Vascular Dilator and the Garrett Vascular Dilator is textured with one site flat. The handles of the Sarns and Myocardial Dilators are smooth. The Myocardial Dilator has a flat distal end for holding it and the Sarns Dilator has a hollow handle at the distal end.
Apart from the Hiebert Vascular Dilator and the Myocardial Dilator, the handle is connected to a thin shaft. The diameter of the shaft of the different dilator types varies. The shaft of the Cooley Coronary Dilator, the Cooley Vessel Dilator, The Garrett Vascular Dilator and the DeBakey Vascular Dilator can be thin so that the shaft is flexible. The handle of the Myocardial Dilator has no shaft while the Hiebert Vascular Dilator is double-ended; it possesses two flexible shafts, with the handle located in between the two thin shafts.
The tips of all dilators have the aim to enlarge a vessel. The design of the Sarns and Myocardial Dilator is similar to an elephant's tusk. The diameter increases steadily, moving towards the handle's direction. The tips of the other Dilators are olive-shaped. The Cooley Coronary Dilator possesses no formed tip. For all dilators, the penetrating diameter corresponds to the diameter of the shaft. The Hiebert Vascular Dilators working elements are each malleable wires with an olive tip in different diameters.
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K Number
K130896Device Name
VASCULAR PROBE, VASCULAR PROBE ES
Manufacturer
SYNOVIS LIFE TECHNOLOGIES, INC.
Date Cleared
2013-04-24
(23 days)
Product Code
DWP
Regulation Number
870.4475Why did this record match?
Product Code :
DWP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable Vascular Probe is intended to be used during coronary and peripheral vascular surgery to probe blood vessels distally and proximally for blockages, to measure the internal diameter of vessels, and to act as an intravascular retractor.
Device Description
The Vascular Probe is a sterile, single use, disposable device with a polyurethane coated streamline bulb on each end of a flexible polycarbonate or polycarbonate-polyurethane shaft. The bulbs are of different size on each end of the Vascular Probe. An appropriately-sized bulb is inserted either proximally or distally through the arteriotomy to probe the interior of the vessel and may be used by the surgeon to retract the vascular wall.
The Vascular Probe is packaged in a double sterile barrier. The contents of the unopened, undamaged container are sterile.
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K Number
K100518Device Name
INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
Manufacturer
INSTRUMED INTERNATIONAL, INC.
Date Cleared
2010-08-31
(189 days)
Product Code
DWP
Regulation Number
870.4475Why did this record match?
Product Code :
DWP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INSTRUMED Vessel Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various manoeuvres of dilation and measurement of annulus and lumen diameters.
Device Description
Instrumed Vessel Dilators are reusable surgical instruments. To ensure the multi-purpose use of this device, different models are available. The differences can be in length, diameter, and design of the dilators. Dilators are used to check patency of vessel in coronary artery bypass procedures, to check patency of other vessels in pheripheral vascular procedures, olive shaped tips (Garrett). The surgeon chooses the instrument based on the anatomy of the vessel and the type desired, and on the type of the surgical procedure. Instrumed Vessel Dilators are made of ASTM F 899-07 standardized Stainless Steel. The instruments are offered in non-sterile condition.
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K Number
K030788Device Name
KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS
Manufacturer
GEISTER MEDIZINTECHNIK GMBH
Date Cleared
2003-07-12
(122 days)
Product Code
DWP
Regulation Number
870.4475Why did this record match?
Product Code :
DWP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GEISTER vessel dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
Device Description
GEISTER vessel dilators
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K Number
K960312Device Name
RDI CARDIAC INSULATION PAD
Manufacturer
R D INTL.
Date Cleared
1996-04-19
(88 days)
Product Code
DWP
Regulation Number
870.4475Why did this record match?
Product Code :
DWP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RDI Cardiac Insulation Pad is intended to be used during open heart surgery to insulate the myocardium from the warmer organs and tissues in the body and thus reduce undesired rewarming of the heart.
Device Description
The RDI Cardiac Insulation Pad consists of a pear shaped, 1/8" thick, closed cell polyethylene foam material. Attached to the foam is a 1/2" wide, 20" long, 4 mil thick, polyvinyl chloride strip referred to as a "tail".
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