Cleared Traditional

K972993 - CHASE FEMORAL ACCESS CANNULATION SET

K972993 is an FDA 510(k) clearance for CHASE FEMORAL ACCESS CANNULATION SET, manufactured by Chase Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K972993 · Chase Medical, Inc. · Cardiovascular device
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Mar 1998
Decision
231d
Days
Class 2
Risk

K972993 is an FDA 510(k) clearance for the CHASE FEMORAL ACCESS CANNULATION SET. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Chase Medical, Inc. (Richardson, US). The FDA issued a Cleared decision on March 31, 1998 after a review of 231 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Chase Medical, Inc. devices

FDA 510(k) Submission Details - K972993

510(k) Number K972993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1997
Decision Date March 31, 1998
Days to Decision 231 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 125d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 335
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K972993.
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
K981601 · Sorin Group Italia S.R.L. · Jul 1998
HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER
K974736 · Heartport, Inc. · Jul 1998
BETTER-TUBING
K964205 · Circulatory Technology, Inc. · Apr 1998
QUEST VESSEL CATHETER
K971928 · Quest Medical, Inc. · Nov 1997
RIVETTI-LEVINSON INSTRALUMINAL SHUNT
K972261 · Integra Neurocare, LLC · Sep 1997
CHASE THORACIC CATHETER
K971023 · Chase Medical, Inc. · Sep 1997