DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET


codes

Device Classification Name

wire, guide, catheter

510(k) Number K001198
Device Name DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET
Original Applicant
DATASCOPE CORP.
15 law dr.
fairfield, 
NJ 
07004 -3206

Original Contact joann wolf
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 04/13/2000
Decision Date 05/12/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No