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FDA 510(k)

PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT

K-Number: K942583 · 1994-07-08

ApplicantBio-Vascular, Inc.
Decision Date1994-07-08
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERI-STRIPS PLANAR CONFIGURATION 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 1994-07-08 under 510(k) number K942583. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT?

PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT is a medical device that received FDA 510(k) clearance on 1994-07-08. The listed applicant is Bio-Vascular, Inc.. The 510(k) number is K942583.

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

PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT received FDA 510(k) clearance on 1994-07-08, under 510(k) number K942583.

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

The FDA product code for PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT is FTL.

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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.

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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: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, 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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