Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PETERS CARDIOFLON(TM) SUTURE

K-Number: K913101 · 1992-08-12

ApplicantPromedica Products, Inc.
Decision Date1992-08-12
Product CodeGAS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PETERS CARDIOFLON(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 1992-08-12 under 510(k) number K913101. The device is classified under product code GAS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PETERS CARDIOFLON(TM) SUTURE?

PETERS CARDIOFLON(TM) SUTURE is a medical device that received FDA 510(k) clearance on 1992-08-12. The listed applicant is Promedica Products, Inc.. The 510(k) number is K913101.

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

PETERS CARDIOFLON(TM) SUTURE received FDA 510(k) clearance on 1992-08-12, under 510(k) number K913101.

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

The FDA product code for PETERS CARDIOFLON(TM) SUTURE is GAS.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K913102PETERS CARDIONYL(TM) SUTUREK892768PATIENT EXAMINATION GLOVES (POLY)K883412THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)K882883C-MASK(FLAT)K882882C-MASK

Related Devices (Code: GAS)

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.

K203120RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 PolypropyleneLsi Solutions, Inc.K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi SolutionsK091018ARTHREX BIOWIREArthrex, Inc.K002261MR-IIISmith & Nephew, Inc.K953128SUTURE CORDPhoenix Biomedical Corp.K923161BRAIDED POLYESTER SUTURE MATERIALMitek Surgical Products, 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.

↑