Cleared Traditional

K912664 - TEC ROTATING DUAL HEMOVALVE

K912664 is the FDA 510(k) clearance for TEC ROTATING DUAL HEMOVALVE by Intensive Technology, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 433-day FDA review.

K912664 · Intensive Technology, Inc. · Cardiovascular device
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Aug 1992
Decision
433d
Days
Class 2
Risk

K912664 is an FDA 510(k) clearance for the TEC ROTATING DUAL HEMOVALVE. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Intensive Technology, Inc. (San Diego, US). The FDA issued a Cleared decision on August 24, 1992 after a review of 433 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Intensive Technology, Inc. devices

Submission Details

510(k) Number K912664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1991
Decision Date August 24, 1992
Days to Decision 433 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
308d slower than avg
Panel avg: 125d · This submission: 433d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 392
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K912664.
INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION
K923603 · Kontron Instruments, Inc. · Mar 1993
OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO
K920907 · Teleflexmedical, Inc. · Oct 1992
OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1
K920908 · Teleflexmedical, Inc. · Oct 1992
CATHETER INTRODUCER
K920528 · Boston Scientific Corp · Aug 1992
FAST-CATH HEMOSTASIS INTRODUCER
K920779 · Daig Corp. · Jun 1992
GORE TUNNELER, MODIFICATION
K920998 · W.L. Gore & Associates, Inc. · Jun 1992