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FDA 510(k)

SHELHIGH PERICARDIAL PATCH

K-Number: K964467 · 1997-09-23

ApplicantShelhigh, Inc.
Decision Date1997-09-23
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHELHIGH PERICARDIAL PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Shelhigh, Inc.. It received FDA 510(k) clearance on 1997-09-23 under 510(k) number K964467. 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 SHELHIGH PERICARDIAL PATCH?

SHELHIGH PERICARDIAL PATCH is a medical device that received FDA 510(k) clearance on 1997-09-23. The listed applicant is Shelhigh, Inc.. The 510(k) number is K964467.

When did SHELHIGH PERICARDIAL PATCH receive FDA 510(k) clearance?

SHELHIGH PERICARDIAL PATCH received FDA 510(k) clearance on 1997-09-23, under 510(k) number K964467.

Who is the listed applicant for SHELHIGH PERICARDIAL PATCH?

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

What is the FDA product code for SHELHIGH PERICARDIAL PATCH?

The FDA product code for SHELHIGH PERICARDIAL PATCH is DXZ.

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Other records listing Shelhigh, 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.

K032893SHELHIGH NO-REACT BIOCUFFK023940SHELHIGH BIORINGK982101SHELHIGH NO-REACT DURA SHIELDK991567SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.K982810SHELHIGH NO-REACT VASCUPATCHK981756SHELHIGH NO-REACT PNEUMOPLEDGETS

View all 8 devices →

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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