Cleared Traditional

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

K897075 is an FDA 510(k) clearance for PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN..., manufactured by Pioneering Technologies, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K897075

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
Combination Product No
PCCP Authorized No
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.

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 155
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K897075.
RMI VASCULAR TOURNIQUET KIT
K910221 · Research Medical, Inc. · May 1991
APPLIED VASCULAR DEVICES 6MM TRACTION CLIP
K901628 · Applied Vascular Devices, Inc. · Jul 1990
ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE
K901565 · Applied Vascular Devices, Inc. · Jun 1990
VASCULAR CLAMP
K895691 · Applied Vascular Devices, Inc. · Dec 1989
ATRAUMAX(TM) SURGICAL CLAMPS
K891296 · Applied Vascular Devices, Inc. · Jun 1989
SURGICAL CLAMP INSERTS
K883790 · Applied Vascular Devices, Inc. · Dec 1988