The following data is part of a premarket notification filed by Clear Stream Technologies, Ltd. with the FDA for Bantam Catheter (280mm Balloon Lengths).
| Device ID | K112335 |
| 510k Number | K112335 |
| Device Name: | BANTAM CATHETER (280MM BALLOON LENGTHS) |
| Classification | Catheter, Percutaneous |
| Applicant | CLEAR STREAM TECHNOLOGIES, LTD. MOYNE UPPER, ENNISCORTHY County Wexford, IE |
| Contact | Fiona Ni Mhullain |
| Correspondent | J.a. Van Vugt 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 | 2011-08-12 |
| Decision Date | 2011-10-12 |
| Summary: | summary |