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FDA 510(k)

PETERS CARDIONYL(TM) SUTURE

K-Number: K913102 · 1992-08-03

ApplicantPromedica Products, Inc.
Decision Date1992-08-03
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PETERS CARDIONYL(TM) SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Promedica Products, Inc.. It received FDA 510(k) clearance on 1992-08-03 under 510(k) number K913102. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PETERS CARDIONYL(TM) SUTURE?

PETERS CARDIONYL(TM) SUTURE is a medical device that received FDA 510(k) clearance on 1992-08-03. The listed applicant is Promedica Products, Inc.. The 510(k) number is K913102.

When did PETERS CARDIONYL(TM) SUTURE receive FDA 510(k) clearance?

PETERS CARDIONYL(TM) SUTURE received FDA 510(k) clearance on 1992-08-03, under 510(k) number K913102.

Who is the listed applicant for PETERS CARDIONYL(TM) SUTURE?

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

What is the FDA product code for PETERS CARDIONYL(TM) SUTURE?

The FDA product code for PETERS CARDIONYL(TM) SUTURE is GAR.

Related Clinical Trials

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 Promedica Products, 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.

K913101PETERS CARDIOFLON(TM) SUTUREK892768PATIENT EXAMINATION GLOVES (POLY)K883412THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)K882883C-MASK(FLAT)K882882C-MASK

Related Devices (Code: GAR)

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.

K261484Tissue Approximation SystemTas Medical, Inc.K220980Tissue Approximation System (TAS)Tas Medical, Inc.K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit SuturesK212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd.K192420Crownjun Nylon SutureKono Seisakusho Co., Ltd.K161633REXLON, REXSILSm Eng Co., Ltd.

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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