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FDA 510(k)

SERAGARD VASCULAR ACCESS DEVICE

K-Number: K963595 · 1997-01-06

ApplicantCutting Edge Technologies, Inc.
Decision Date1997-01-06
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SERAGARD VASCULAR ACCESS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Cutting Edge Technologies, Inc.. It received FDA 510(k) clearance on 1997-01-06 under 510(k) number K963595. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERAGARD VASCULAR ACCESS DEVICE?

SERAGARD VASCULAR ACCESS DEVICE is a medical device that received FDA 510(k) clearance on 1997-01-06. The listed applicant is Cutting Edge Technologies, Inc.. The 510(k) number is K963595.

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

SERAGARD VASCULAR ACCESS DEVICE received FDA 510(k) clearance on 1997-01-06, under 510(k) number K963595.

Who is the listed applicant for SERAGARD VASCULAR ACCESS DEVICE?

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

What is the FDA product code for SERAGARD VASCULAR ACCESS DEVICE?

The FDA product code for SERAGARD VASCULAR ACCESS DEVICE is FMI.

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 Cutting Edge Technologies, 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.

K952606TARGETT PATCH

Related Devices (Code: FMI)

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Official Source

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