The following data is part of a premarket notification filed by Clearstream Technologies, Ltd. with the FDA for Reekross Family Or Otw Pta Catheters.
| Device ID | K083596 |
| 510k Number | K083596 |
| Device Name: | REEKROSS FAMILY OR OTW PTA CATHETERS |
| Classification | Catheter, Percutaneous |
| Applicant | CLEARSTREAM TECHNOLOGIES, LTD. MOYNE UPPER, ENNISCORTHY County Wexford, IE |
| Contact | Fiona N Mhullain |
| Correspondent | J Schakenraad DEKRA CERTIFICATION B.V. UTRECHTSEWEG 310 Arnhem, NL Nl-6812 Ar |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-12-05 |
| Decision Date | 2009-03-02 |
| Summary: | summary |