Cleared Traditional

K102633 - BIOTEQ ANGIOGRAPHIC CATHETER

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

K102633 · Bioteque Corp. · Cardiovascular device
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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

FDA 510(k) Submission Details - K102633

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.

DQO Device Classification - Class 2, Special Controls

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 390
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K102633.
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