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FDA 510(k)

PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT

K-Number: K971048 · 1997-05-09

ApplicantBio-Vascular, Inc.
Decision Date1997-05-09
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT 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 1997-05-09 under 510(k) number K971048. 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 PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT?

PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT is a medical device that received FDA 510(k) clearance on 1997-05-09. The listed applicant is Bio-Vascular, Inc.. The 510(k) number is K971048.

When did PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT receive FDA 510(k) clearance?

PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT received FDA 510(k) clearance on 1997-05-09, under 510(k) number K971048.

Who is the listed applicant for PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT?

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 PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT?

The FDA product code for PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT 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

View all 26 devices →

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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