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FDA 510(k)

SCI MED PERICARDIAL SUBSTITUTE

K-Number: K791792 · 1979-12-07

ApplicantScimed Life Systems, Inc.
Decision Date1979-12-07
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCI MED PERICARDIAL SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Life Systems, Inc.. It received FDA 510(k) clearance on 1979-12-07 under 510(k) number K791792. 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 SCI MED PERICARDIAL SUBSTITUTE?

SCI MED PERICARDIAL SUBSTITUTE is a medical device that received FDA 510(k) clearance on 1979-12-07. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K791792.

When did SCI MED PERICARDIAL SUBSTITUTE receive FDA 510(k) clearance?

SCI MED PERICARDIAL SUBSTITUTE received FDA 510(k) clearance on 1979-12-07, under 510(k) number K791792.

Who is the listed applicant for SCI MED PERICARDIAL SUBSTITUTE?

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

What is the FDA product code for SCI MED PERICARDIAL SUBSTITUTE?

The FDA product code for SCI MED PERICARDIAL SUBSTITUTE is DXZ.

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Other records listing Scimed Life Systems, 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.

K974241SCIMED INFORMER PRESSURE WIRE SYSTEMK981788SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETERK980360SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRESK974559SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERSK974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETERK973945LUGE GUIDE WIRE

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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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