Cleared Traditional

K193474 - Selectra 3D Outer Guiding Catheters

K193474 is the FDA 510(k) clearance for Selectra 3D Outer Guiding Catheters by Biotronik, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K193474 · Biotronik, Inc. · Cardiovascular device
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Oct 2020
Decision
305d
Days
Class 2
Risk

K193474 is an FDA 510(k) clearance for the Selectra 3D Outer Guiding Catheters. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on October 16, 2020 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Biotronik, Inc. devices

Submission Details

510(k) Number K193474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2019
Decision Date October 16, 2020
Days to Decision 305 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 125d · This submission: 305d
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 573
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K193474.
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K192712 · Medtronic, Inc. · Aug 2020