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FDA 510(k)

CV PERI-GUARD AND VASCU-GUARD

K-Number: K983602 · 1998-11-12

ApplicantBio-Vascular, Inc.
Decision Date1998-11-12
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CV PERI-GUARD AND VASCU-GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Vascular, Inc.. It received FDA 510(k) clearance on 1998-11-12 under 510(k) number K983602. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CV PERI-GUARD AND VASCU-GUARD?

CV PERI-GUARD AND VASCU-GUARD is a medical device that received FDA 510(k) clearance on 1998-11-12. The listed applicant is Bio-Vascular, Inc.. The 510(k) number is K983602.

When did CV PERI-GUARD AND VASCU-GUARD receive FDA 510(k) clearance?

CV PERI-GUARD AND VASCU-GUARD received FDA 510(k) clearance on 1998-11-12, under 510(k) number K983602.

Who is the listed applicant for CV PERI-GUARD AND VASCU-GUARD?

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

What is the FDA product code for CV PERI-GUARD AND VASCU-GUARD?

The FDA product code for CV PERI-GUARD AND VASCU-GUARD is DXZ.

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Other records listing Bio-Vascular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K002233BVI SLINGK992537PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATEDK983581OCU-GUARD AND OCU-GUARD SUPPLEK983162PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASCK981624FLO-THRUK982282DURA-GUARD - DURAL REPAIR PATCH

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Related Devices (Code: DXZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240775PeriBeam® Pericardial MembraneTamabioK200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd.K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc.K162579VascuCelAdmedus Regen Pty, Ltd.K152127CorMatrix TykeCormatrix Cardiovascular, Inc.K122306SYNOVIS COLLAGEN MATRIX (TBD)Synovis Surgical Innovations

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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