The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Rebar Micro Catheter: Rebar-18 [2.3f], 110 Cm, 130 Cm, 153 Cm, Single Marker Band And 153 Cm, Dual Marker Band.
| Device ID | K001966 |
| 510k Number | K001966 |
| Device Name: | REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND |
| Classification | Catheter, Continuous Flush |
| Applicant | MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Contact | Maribelle Aguinaldo |
| Correspondent | Maribelle Aguinaldo MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-28 |
| Decision Date | 2000-07-20 |