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Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA product code PRC · Class 3 · Unknown
265
Registered devices
525
Adverse events
1
Recalls
0
510(k) clearances
Devices with this code
LUTONIX ® 035 Drug Coated Balloon PTA Catheter — LUTONIX, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.IN.PACT™ AV — MEDTRONIC, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.LUTONIX ® 035 Drug Coated Balloon PTA Catheter — LUTONIX, INC.LUTONIX ® 035 Drug Coated Balloon PTA Catheter — LUTONIX, INC.IN.PACT™ AV — MEDTRONIC, INC.IN.PACT™ AV — MEDTRONIC, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.LUTONIX ® 035 Drug Coated Balloon PTA Catheter — LUTONIX, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.IN.PACT™ AV — MEDTRONIC, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.LUTONIX ® 035 Drug Coated Balloon PTA Catheter — LUTONIX, INC.IN.PACT™ AV — MEDTRONIC, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-23 | Medtronic Vascular, Inc. | Packaging for Balloon Catheters may be damaged resulting in loss of sterility. |
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