Cleared Traditional

K903217 - TAPERED TIP THE GUIDER CORONARY GUIDING...

K903217 is the FDA 510(k) clearance for TAPERED TIP THE GUIDER CORONARY GUIDING... by Intec Medical, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K903217 · Intec Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
88d
Days
Class 2
Risk

K903217 is an FDA 510(k) clearance for the TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Intec Medical, Inc. (Danvers, US). The FDA issued a Cleared decision on October 19, 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 870.1250 - 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 Intec Medical, Inc. devices

Submission Details

510(k) Number K903217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1990
Decision Date October 19, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
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.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 484
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K903217.
MULTI-LUMEN CENTRAL VENOUS CATHETER SET
K904404 · Arrow Intl., Inc. · Feb 1991
VASCULAR RETRIEVAL FORCEPS
K902999 · Cook, Inc. · Feb 1991
ACS URETHAN CORONARY GUIDING CATHETER
K904884 · Advanced Cardiovascular Systems, Inc. · Jan 1991
COOK CORONARY GUIDING CATHETER
K902905 · Cook, Inc. · Sep 1990
CURITY(R) PERCUTANEOUS CATHETERS
K895972 · Kendall Healthcare Products Co. Div.Of Tyco Health · Mar 1990
QUINTON MAHURKAR CATHETERS W/VITACUFF
K895440 · Quinton, Inc. · Nov 1989