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FDA 510(k)

SURGISIS PERIPHERAL VASCULAR PATCH

K-Number: K001785 · 2000-12-27

ApplicantCook Biotech, Inc.
Decision Date2000-12-27
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SURGISIS PERIPHERAL VASCULAR PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech, Inc.. It received FDA 510(k) clearance on 2000-12-27 under 510(k) number K001785. 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 SURGISIS PERIPHERAL VASCULAR PATCH?

SURGISIS PERIPHERAL VASCULAR PATCH is a medical device that received FDA 510(k) clearance on 2000-12-27. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K001785.

When did SURGISIS PERIPHERAL VASCULAR PATCH receive FDA 510(k) clearance?

SURGISIS PERIPHERAL VASCULAR PATCH received FDA 510(k) clearance on 2000-12-27, under 510(k) number K001785.

Who is the listed applicant for SURGISIS PERIPHERAL VASCULAR PATCH?

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

What is the FDA product code for SURGISIS PERIPHERAL VASCULAR PATCH?

The FDA product code for SURGISIS PERIPHERAL VASCULAR PATCH is DXZ.

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Other records listing Cook Biotech, 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.

K131015BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFTK111695HYBRID GRAFTK110402BIODESIGN NIPPLE RECONSTRUCTION CYLINDERK090688COOK UROLOGICAL GRAFTK082682SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUGK082058DYNAMATRIX

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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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