Cleared Traditional

K901247 - TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES

K901247 is the FDA 510(k) clearance for TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES by Intec Medical, Inc.. It is a Class 2 Cardiovascular device (product code DYG) cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K901247 · Intec Medical, Inc. · Cardiovascular device
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Jul 1990
Decision
138d
Days
Class 2
Risk

K901247 is an FDA 510(k) clearance for the TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Intec Medical, Inc. (Danvers, US). The FDA issued a Cleared decision on July 31, 1990 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 Intec Medical, Inc. devices

Submission Details

510(k) Number K901247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1990
Decision Date July 31, 1990
Days to Decision 138 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 41
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K901247.
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT
K934742 · Baxter Healthcare Corp · Jan 1994
SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER
K924452 · Baxter Healthcare Corp · Oct 1993
STEALTH DILATION CATHETER SYSTEM/MODIFICATION
K904287 · Target Therapeutics · Jan 1991
SOFT-WEDGE(TM) SYRINGE
K900879 · Baxter Healthcare Corp · May 1990
SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME
K896466 · Baxter Healthcare Corp · Feb 1990
CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
K892530 · Arrow Intl., Inc. · Sep 1989