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ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEN

FDA premarket approval P980037/S024 · decided 2008-06-17

Approval details

PMA number
P980037
Supplement
S024
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEN
Generic name
CATHETER, CORONARY, ATHERECTOMY
Applicant
Boston Scientific Corp
Date received
2007-12-20
Decision date
2008-06-17
Days to decision
180 days
Decision code
APPR
Product code
MCX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
APPROVAL FOR AN ALTERNATIVE HYDROPHILIC COATING MATERIAL AND SUPPLIER (DSM BIOMEDICAL, GLEEN, NETHERLANDS) USED ON THE DISTAL SHAFT OF THE SPIROFLEX FAMILY OF CATHETERS (SPIROFLEX AND SPRIOFLEX VG) AND APPROVAL TO PERFORM THE MANUFACTURING COATING PROCESS OF THE NEW DSM HYDROPHILIC COATING AT THE POSSIS FACILITY, MINNEAPOLIS, MINNESOTA.

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510(k) clearances by this applicant

RecordFirmDate
IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245)Boston Scientific Corp2024-10-18
LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328)Boston Scientific Corp2023-08-19
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853)Boston Scientific Corp2015-11-20
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21