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FDA 510(k)

BONCHEK-SHILEY VEIN DISTENTION SYSTEM

K-Number: K792134 · 1979-12-04

ApplicantShiley, Inc.
Decision Date1979-12-04
Product CodeDWP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BONCHEK-SHILEY VEIN DISTENTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1979-12-04 under 510(k) number K792134. The device is classified under product code DWP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONCHEK-SHILEY VEIN DISTENTION SYSTEM?

BONCHEK-SHILEY VEIN DISTENTION SYSTEM is a medical device that received FDA 510(k) clearance on 1979-12-04. The listed applicant is Shiley, Inc.. The 510(k) number is K792134.

When did BONCHEK-SHILEY VEIN DISTENTION SYSTEM receive FDA 510(k) clearance?

BONCHEK-SHILEY VEIN DISTENTION SYSTEM received FDA 510(k) clearance on 1979-12-04, under 510(k) number K792134.

Who is the listed applicant for BONCHEK-SHILEY VEIN DISTENTION SYSTEM?

The FDA 510(k) record lists Shiley, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONCHEK-SHILEY VEIN DISTENTION SYSTEM?

The FDA product code for BONCHEK-SHILEY VEIN DISTENTION SYSTEM is DWP.

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Other records listing Shiley, Inc. as applicant

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K920594SHILEY PERFUSION TUBING SETSK910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMK911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200K910923BCD ADVANCEDK901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASK903435SHILEY SPECIALIZED TRACHEOSTOMY TUBE

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Related Devices (Code: DWP)

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K220981SUPERPLAST Double-Occluder, SUPERPLAST Vascular ProbeFehling Surgical Instruments, Inc.K183438Geomed Vascular DilatorsGeomed Medizin-Technik GmbH & Co.K163524Vessel DilatorFetzer Medical GmbH & Co. KGK130896VASCULAR PROBE, VASCULAR PROBE ESSynovis Life Technologies, Inc.K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054Instrumed International, Inc.K030788KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORSGeister Medizin Technik GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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