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Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA product code ONU · Class 3 · Unknown

658
Registered devices
5,888
Adverse events
1
Recalls
0
510(k) clearances

Devices with this code

Ranger™ — BOSTON SCIENTIFIC CORPORATIONLUTONIX® Drug Coated Balloon — LUTONIX, INC.Ranger™ — BOSTON SCIENTIFIC CORPORATIONStellarex 0.035" OTW drug-coated angioplasty balloon — Philips Image Guided Therapy CorporationIn.Pact™ 018 — MEDTRONIC, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.SurVeil DCB — Surmodics, Inc.LUTONIX® Drug Coated Balloon — LUTONIX, INC.Stellarex — Spectranetics CorporationStellarex — Philips Image Guided Therapy CorporationStellarex 0.035" OTW drug-coated angioplasty balloon — Philips Image Guided Therapy CorporationIn.Pact™ 018 — MEDTRONIC, INC.IN.PACT™ Admiral™ — MEDTRONIC, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.SurVeil DCB — Surmodics, Inc.Ranger™ — BOSTON SCIENTIFIC CORPORATIONRanger™ — BOSTON SCIENTIFIC CORPORATIONLUTONIX® Drug Coated Balloon — LUTONIX, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.LUTONIX® Drug Coated Balloon — LUTONIX, INC.Stellarex — Spectranetics CorporationLUTONIX® Drug Coated Balloon — LUTONIX, INC.

Recent recalls

DateFirmReason
2022-03-23Medtronic Vascular, Inc.Packaging for Balloon Catheters may be damaged resulting in loss of sterility.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.