Cleared Traditional

K901628 - APPLIED VASCULAR DEVICES 6MM TRACTION CLIP

K901628 is an FDA 510(k) clearance for APPLIED VASCULAR DEVICES 6MM TRACTION CLIP, manufactured by Applied Vascular Devices, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K901628 · Applied Vascular Devices, Inc. · Cardiovascular device
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Jul 1990
Decision
88d
Days
Class 2
Risk

K901628 is an FDA 510(k) clearance for the APPLIED VASCULAR DEVICES 6MM TRACTION CLIP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Applied Vascular Devices, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on July 6, 1990 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Applied Vascular Devices, Inc. devices

FDA 510(k) Submission Details - K901628

510(k) Number K901628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1990
Decision Date July 06, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXC Clamp, Vascular

All 156
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K901628.
SILCLAMPS DEGANIA SILICONE
K920501 · Puritas Health Care, Inc. · Jun 1992
FEMOSTOP
K915280 · Radi Medical Systems AB · Apr 1992
RMI VASCULAR TOURNIQUET KIT
K910221 · Research Medical, Inc. · May 1991
ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE
K901565 · Applied Vascular Devices, Inc. · Jun 1990
PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER
K897075 · Pioneering Technologies, Inc. · Apr 1990
VASCULAR CLAMP
K895691 · Applied Vascular Devices, Inc. · Dec 1989