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Spectranetics Corporation

16 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant( recall (Z-1070-2025)Spectranetics Corporation2025-02-14
Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 41 recall (Z-0680-2025)Spectranetics Corporation2024-12-16
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turb recall (Z-0509-2024)Spectranetics Corporation2023-12-08
Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures w recall (Z-0221-2023)Spectranetics Corporation2022-11-11
Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compa recall (Z-3106-2017)Spectranetics Corporation2017-08-26
Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters D recall (Z-2863-2017)Spectranetics Corporation2017-07-14
Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417 recall (Z-0661-2017)Spectranetics Corporation2016-11-28
ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 1 recall (Z-0662-2017)Spectranetics Corporation2016-11-28
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena c recall (Z-0663-2017)Spectranetics Corporation2016-11-28
Spectranetics Turbo-Booster Laser Guide Catheter, 7 Fr, REF 518-043, Sterile EO, Spectrane recall (Z-2951-2011)Spectranetics Corporation2011-08-04
Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO, Spectrane recall (Z-2952-2011)Spectranetics Corporation2011-08-04
Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working recall (Z-2190-2010)Spectranetics Corporation2010-08-09
Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter in recall (Z-1264-2009)Spectranetics Corporation2009-06-01
Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, s recall (Z-0976-2009)Spectranetics Corporation2009-02-11
Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually package recall (Z-0903-2009)Spectranetics Corporation2009-01-30
Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufa recall (Z-0698-2008)Spectranetics Corporation2008-02-05

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