Cleared Traditional

K900998 - INTERVENTIONAL MEDICAL Y ADAPTER W/ADJU...

K900998 is the FDA 510(k) clearance for INTERVENTIONAL MEDICAL Y ADAPTER W/ADJU... by Intec Medical, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K900998 · Intec Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
166d
Days
Class 2
Risk

K900998 is an FDA 510(k) clearance for the INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE. 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 August 14, 1990 after a review of 166 days - an extended review 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: 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 K900998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1990
Decision Date August 14, 1990
Days to Decision 166 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 125d · This submission: 166d
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 K900998.
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
TARGET THERAPEUTICS TRACKER LF CATHETER
K894105 · Target Therapeutics · Sep 1989