FDA 510(k)

VASCULAR CLOSURE DEVICE

K-Number: K003169 · 2000-12-08

Decision Date2000-12-08

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

VASCULAR CLOSURE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Std Mfg., Inc.. It received FDA 510(k) clearance on 2000-12-08 under 510(k) number K003169. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCULAR CLOSURE DEVICE?

VASCULAR CLOSURE DEVICE is a medical device that received FDA 510(k) clearance on 2000-12-08. The listed applicant is Std Mfg., Inc.. The 510(k) number is K003169.

When did VASCULAR CLOSURE DEVICE receive FDA 510(k) clearance?

VASCULAR CLOSURE DEVICE received FDA 510(k) clearance on 2000-12-08, under 510(k) number K003169.

Who is the listed applicant for VASCULAR CLOSURE DEVICE?

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

What is the FDA product code for VASCULAR CLOSURE DEVICE?

The FDA product code for VASCULAR CLOSURE DEVICE is GDW.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Std Mfg., Inc. as applicant

K023096CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM K021549CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM K012362MODIFICATION TO VASCULAR CLOSURE DEVICE K000608SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM K930427STD IRRIGATION PUMP

Related Devices (Code: GDW)

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.