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The Spectranetics Corp.

25 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (P160049/S027)The Spectranetics Corp.2025-11-24
Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (P160049/S025)The Spectranetics Corp.2024-08-07
Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (P160049/S024)The Spectranetics Corp.2024-06-17
Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (P160049/S023)The Spectranetics Corp.2024-05-22
Stellarex™ 0.035” OTW Drug-Coated Angioplasty Balloon (P160049/S022)The Spectranetics Corp.2023-12-05
Sterallex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (P160049/S021)The Spectranetics Corp.2023-05-23
Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (P160049/S020)The Spectranetics Corp.2023-03-21
Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (P160049/S019)The Spectranetics Corp.2022-07-15
Stellarex 035 Drug Coated Ballon Percutaneous Transluminal Angioplasty Catheter (P160049/S018)The Spectranetics Corp.2022-06-22
Stellarex 0.035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (P160049/S017)The Spectranetics Corp.2022-04-11
Stellarex 0.035OTW Drug-coated Angioplasty Balloon (P160049/S015)The Spectranetics Corp.2022-03-25
Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (P160049/S013)The Spectranetics Corp.2021-11-18
Stellarex™ 0.035” OTW Drug-coated Angioplasty Balloon (P160049/S012)The Spectranetics Corp.2021-10-28
Stellarex 0.035” OTW Drug-coated Angioplasty Balloon (P160049/S010)The Spectranetics Corp.2021-10-28
Stellarex 035 OTW Drug-Coated Angiopiasty Balloon (DCB) (P160049/S011)The Spectranetics Corp.2021-02-19
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S008)The Spectranetics Corp.2020-02-11
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S004)The Spectranetics Corp.2019-10-11
Stellarex 0.035 OTW Drug-coated Angioplasty Ballon (P160049/S007)The Spectranetics Corp.2019-09-13
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S006)The Spectranetics Corp.2019-06-12
Stellarex 0.035 OTW Drug-coated Angioplasty Ballon (P160049/S005)The Spectranetics Corp.2019-05-03
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON (P160049/S003)The Spectranetics Corp.2018-11-16
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S002)The Spectranetics Corp.2018-03-12
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S001)The Spectranetics Corp.2017-10-23
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON (P160049)The Spectranetics Corp.2017-07-26

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Every clearance here is in the API, with alerts when new ones post.