Cleared Special

Phenom 27 Catheter (K180959) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K180959 · Cathera, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2018
Decision
60d
Days
Class 2
Risk

K180959 is an FDA 510(k) clearance for the Phenom 27 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 June 11, 2018 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cathera, Inc. devices

Submission Details

510(k) Number K180959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2018
Decision Date June 11, 2018
Days to Decision 60 days
Submission Type Special
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
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

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 390
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K180959.
EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length
K180169 · Imperative Care, Inc. · Aug 2018
WATCHMAN TruSeal Access System
K180864 · Boston Scientific · Jul 2018
React 68 Catheter
K180715 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jul 2018
Route 92 Medical Access System
K180201 · Route 92 Medical, Inc. · May 2018
XableCath Support Catheter Product Family
K180986 · Xablecath, Inc. · May 2018
Wingman 35 Crossing Catheter
K173661 · Reflow Medical, Inc. · Apr 2018