Cleared Traditional

K102633 - BIOTEQ ANGIOGRAPHIC CATHETER

K102633 is the FDA 510(k) clearance for BIOTEQ ANGIOGRAPHIC CATHETER by Bioteque Corp.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 361-day FDA review.

K102633 · Bioteque Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
361d
Days
Class 2
Risk

K102633 is an FDA 510(k) clearance for the BIOTEQ ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Bioteque Corp. (Flagstaff, US). The FDA issued a Cleared decision on September 9, 2011 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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. Elevated predicate reliance profile. 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 Bioteque Corp. devices

Submission Details

510(k) Number K102633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2010
Decision Date September 09, 2011
Days to Decision 361 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
236d slower than avg
Panel avg: 125d · This submission: 361d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 265
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K102633.
ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
K112452 · AngioDynamics, Inc. · Mar 2012
IMAGER II ANGIOGRAPHIC CATHETERS
K120893 · Boston Scientific Corp · Mar 2012
MODIFIED CONCENTIRC MICROCATHETER
K113260 · Concentric Medical, Inc. · Mar 2012
MODIFIED CONCENTRIC MICROCATHETER
K111619 · Concentric Medical, Inc. · Jul 2011
MERIT MARQUIS FLOW SWITCH
K110643 · Merit Medical Systems, Inc. · Jul 2011
EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
K110103 · Edwards Lifesciences, LLC · Feb 2011