Cleared Traditional

K151638 - Phenom 17 Catheter

K151638 is an FDA 510(k) clearance for Phenom 17 Catheter, manufactured by Cathera, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K151638 · Cathera, Inc. · Cardiovascular device
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Nov 2015
Decision
149d
Days
Class 2
Risk

K151638 is an FDA 510(k) clearance for the Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cathera, Inc. (Mountain View, US). The FDA issued a Cleared decision on November 13, 2015 after a review of 149 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Cathera, Inc. devices

FDA 510(k) Submission Details - K151638

510(k) Number K151638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2015
Decision Date November 13, 2015
Days to Decision 149 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
24d slower than avg
Panel avg: 125d · This submission: 149d
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 647
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K151638.
ASAHI Caravel
K152447 · Asahi Intecc Co., Ltd. · Jan 2016
Stingray LP Catheter
K152401 · Boston Scientific Corporation · Dec 2015
Lantern Delivery Microcatheter
K152840 · Penumbra, Inc. · Dec 2015
AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
K151667 · Stryker · Nov 2015
Selectra Catheters and Selectra Accessory Kit
K151409 · Biotronik, Inc. · Aug 2015
ASAHI Corsair Microcatheter
K151103 · Asahi Intecc Co., Ltd. · Jun 2015