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)

NEXTSTITCH CARDIOVASCULAR VALVE SUTURE

K-Number: K001440 · 2000-11-13

ApplicantGenzyme Surgical Product (Genzyme Biosurgery)
Decision Date2000-11-13
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEXTSTITCH CARDIOVASCULAR VALVE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Surgical Product (Genzyme Biosurgery). It received FDA 510(k) clearance on 2000-11-13 under 510(k) number K001440. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXTSTITCH CARDIOVASCULAR VALVE SUTURE?

NEXTSTITCH CARDIOVASCULAR VALVE SUTURE is a medical device that received FDA 510(k) clearance on 2000-11-13. The listed applicant is Genzyme Surgical Product (Genzyme Biosurgery). The 510(k) number is K001440.

When did NEXTSTITCH CARDIOVASCULAR VALVE SUTURE receive FDA 510(k) clearance?

NEXTSTITCH CARDIOVASCULAR VALVE SUTURE received FDA 510(k) clearance on 2000-11-13, under 510(k) number K001440.

Who is the listed applicant for NEXTSTITCH CARDIOVASCULAR VALVE SUTURE?

The FDA 510(k) record lists Genzyme Surgical Product (Genzyme Biosurgery) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEXTSTITCH CARDIOVASCULAR VALVE SUTURE?

The FDA product code for NEXTSTITCH CARDIOVASCULAR VALVE SUTURE is GAT.

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 Genzyme Surgical Product (Genzyme Biosurgery) 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.

K001434'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTUREK992088BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREK991416ENDOSCOPIC CAMERAK991191BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREK990062SAPHLIFTK982712RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250

View all 9 devices →

Related Devices (Code: GAT)

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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, 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.

↑