Cleared Special

K992622 - INTRAMAX ITI GUIDE CATHETER

K992622 is an FDA 510(k) clearance for INTRAMAX ITI GUIDE CATHETER, manufactured by Intratherapeutics, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 55-day FDA review.

K992622 · Intratherapeutics, Inc. · Cardiovascular device
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Sep 1999
Decision
55d
Days
Class 2
Risk

K992622 is an FDA 510(k) clearance for the INTRAMAX ITI GUIDE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Intratherapeutics, Inc. (Saint Paul, US). The FDA issued a Cleared decision on September 29, 1999 after a review of 55 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Intratherapeutics, Inc. devices

FDA 510(k) Submission Details - K992622

510(k) Number K992622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1999
Decision Date September 29, 1999
Days to Decision 55 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 125d · This submission: 55d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

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 601
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K992622.
5F GUIDING CATHETER
K000598 · Guidant Corp. · Mar 2000
VERIPATH PERIPHERAL GUIDING CATHETER
K994229 · Advanced Cardiovascular Systems, Inc. · Feb 2000
VISTA BRITE TIP CATHETERS
K992673 · Cordis Corp. · Oct 1999
ENVY GUIDING CATHETER
K990726 · Cook, Inc. · Apr 1999
GT LEGGIERO
K981359 · Terumo Medical Corp. · Jan 1999
URESIL VASCU-FLO INFUSION CATHETER
K980278 · Uresil Corp. · Nov 1998