ClearanceBrief
Panels › Cardiovascular › Product code PDU · Class 2

Catheter For Crossing Total Occlusions

Regulation 870.1250

1510(k)s in 12 months (58 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in PDU

Company510(k)sRecalls
Avinger, Inc.100
Ra Medical Systems,Inc35
Spectranetics Corp.70
Cordis Corp., A Johnson & Johnson Co.40
Flowcardia, Inc.30
Lumend, Inc.30
Baylis Medical Co., Inc.20
Baylis Medical Technologies, Inc.20
Boston Scientific Corp20
C.R. Bard, Inc.20
DateFirm and productCodeLinked 510(k)
Jan 5, 2024Bard Peripheral Vascular Inc
BD Recanalization System, REF: BDRECANSYSTEM
Open, Classified		 PDUK203363
Oct 16, 2020Ra Medical Systems, Inc.
DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomati
Terminated		 PDUK170349
Jul 24, 2020Ra Medical Systems, Inc.
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
Terminated		 PDUK170349
Jul 4, 2020Ra Medical Systems, Inc.
DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to
Terminated		 PDUK170349
Sep 19, 2019Ra Medical Systems, Inc.
Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised
Terminated		 PDUK170349
Feb 15, 2018Ra Medical Systems Inc
The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-cont
Terminated		 PDUK170349
Sep 2, 2015Volcano Corporation
Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus
Terminated		 PDUK081804
K101777

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