Cleared Traditional

K192712 - Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter

K192712 is an FDA 510(k) clearance for Attain Select II + SureValve delivery c..., manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K192712 · Medtronic, Inc. · Cardiovascular device
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Aug 2020
Decision
311d
Days
Class 2
Risk

K192712 is an FDA 510(k) clearance for the Attain Select II + SureValve delivery catheter system, Attain Command + SureV.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medtronic, Inc. (Galway, IE). The FDA issued a Cleared decision on August 3, 2020 after a review of 311 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 Medtronic, Inc. devices

FDA 510(k) Submission Details - K192712

510(k) Number K192712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2019
Decision Date August 03, 2020
Days to Decision 311 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
186d slower than avg
Panel avg: 125d · This submission: 311d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 780
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K192712.
Selectra 3D Outer Guiding Catheters
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K202252 · Asahi Intecc Co., Ltd. · Sep 2020
NHancer Rx
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BOBBY Balloon Guide Catheter
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Twin-Pass Dual Access Catheter
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Benchmark BMX96 Access System
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