Cleared Traditional

K897075 - PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN...

K897075 is the FDA 510(k) clearance for PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN... by Pioneering Technologies, Inc.. It is a Class 2 Cardiovascular device (product code DXC) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K897075 · Pioneering Technologies, Inc. · Cardiovascular device
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Apr 1990
Decision
111d
Days
Class 2
Risk

K897075 is an FDA 510(k) clearance for the PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Pioneering Technologies, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on April 10, 1990 after a review of 111 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Pioneering Technologies, Inc. devices

Submission Details

510(k) Number K897075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1989
Decision Date April 10, 1990
Days to Decision 111 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 125d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 62
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K897075.
ATRAUMAX SURGICAL CLAMP
K950492 · Applied Medical Resources · May 1995
RMI EXTERNAL CORONARY ARTERY OCCLUDER
K920936 · Research Medical, Inc. · Dec 1992
RMI VASCULAR TOURNIQUET KIT
K910221 · Research Medical, Inc. · May 1991
AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
K875090 · United States Surgical, A Division of Tyco Healthc · Feb 1988
MICRO ANASTOMOSIS CLAMP
K861924 · Pilling Co. · Jun 1986
FOGARTY 6MM SOFTJAW CLIP
K832554 · American Edwards Laboratories · Sep 1983