Submission Details
| 510(k) Number | K242419 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 15, 2024 |
| Decision Date | November 15, 2024 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Nov 2024
Decision
92d
Days
Class 2
Risk
About This 510(k) Submission
K242419 is an FDA 510(k) clearance for the 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Creagh Medical Ltd. Dba Surmodics, Inc. (Ballinasloe, IE). The FDA issued a Cleared decision on November 15, 2024, 92 days after receiving the submission on August 15, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | LIT — Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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