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FDA 510(k)

CHASE CARDIOVASCULAR PATCH

K-Number: K003467 · 2001-01-29

ApplicantChase Medical, Inc.
Decision Date2001-01-29
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CHASE CARDIOVASCULAR PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Chase Medical, Inc.. It received FDA 510(k) clearance on 2001-01-29 under 510(k) number K003467. 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 CHASE CARDIOVASCULAR PATCH?

CHASE CARDIOVASCULAR PATCH is a medical device that received FDA 510(k) clearance on 2001-01-29. The listed applicant is Chase Medical, Inc.. The 510(k) number is K003467.

When did CHASE CARDIOVASCULAR PATCH receive FDA 510(k) clearance?

CHASE CARDIOVASCULAR PATCH received FDA 510(k) clearance on 2001-01-29, under 510(k) number K003467.

Who is the listed applicant for CHASE CARDIOVASCULAR PATCH?

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

What is the FDA product code for CHASE CARDIOVASCULAR PATCH?

The FDA product code for CHASE CARDIOVASCULAR PATCH is DXZ.

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Other records listing Chase Medical, 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.

K032531CHASE CARDIAC ANALYSIS SYSTEMK022093CHASE CARDIOVASCULAR PATCH KITK021129CHARE CARIOVASCULAR PATCHK020233CHASE CARDIOVASCULAR PATCH KITK020132CHASE CARDIOVASCULAR PATCH KITK012248CHASE CARDIOVASCULAR 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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