Cleared Traditional

Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter (K200700) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200700 · Creagh Medical, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
58d
Days
Class 2
Risk

K200700 is an FDA 510(k) clearance for the Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angiopl.... Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Creagh Medical, Ltd. (Ballinasloe, IE). The FDA issued a Cleared decision on May 14, 2020 after a review of 58 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Creagh Medical, Ltd. devices

Submission Details

510(k) Number K200700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2020
Decision Date May 14, 2020
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 167
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K200700.
SABER .035 PTA Dilatation Catheter
K201333 · Cordis Corporation · Sep 2020
Jade
K201794 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Jul 2020
Infinity Angioplasty Balloon Catheter
K192399 · Infinity Angioplasty Balloon Company, LLC · May 2020
All’InCath 035M PTA Balloon Dilatation Catheter
K191275 · Nexstep Medical · Jan 2020
Advocate PTA Catheter
K192907 · Merit Medical Systems, Inc. · Nov 2019
Cronus HP PTA Balloon Catheter
K190037 · Nipro Medical Corporation · Oct 2019