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FDA 510(k)

SUPPLE PERI-GUARD PERICARDIUM

K-Number: K961810 · 1996-06-13

ApplicantBio-Vascular, Inc.
Decision Date1996-06-13
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUPPLE PERI-GUARD PERICARDIUM 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 1996-06-13 under 510(k) number K961810. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPPLE PERI-GUARD PERICARDIUM?

SUPPLE PERI-GUARD PERICARDIUM is a medical device that received FDA 510(k) clearance on 1996-06-13. The listed applicant is Bio-Vascular, Inc.. The 510(k) number is K961810.

When did SUPPLE PERI-GUARD PERICARDIUM receive FDA 510(k) clearance?

SUPPLE PERI-GUARD PERICARDIUM received FDA 510(k) clearance on 1996-06-13, under 510(k) number K961810.

Who is the listed applicant for SUPPLE PERI-GUARD PERICARDIUM?

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 SUPPLE PERI-GUARD PERICARDIUM?

The FDA product code for SUPPLE PERI-GUARD PERICARDIUM is FTM.

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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-TREATEDK983602CV PERI-GUARD AND VASCU-GUARDK983581OCU-GUARD AND OCU-GUARD SUPPLEK983162PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASCK981624FLO-THRU

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Related Devices (Code: FTM)

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.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc.

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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