The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Rebar Micro Catheter: Rebar-10 (1.7f), 153 Cm, Dual Marker Bands; Rebar Micro Catheter: Rebar-10 (1.7f), 170 Cm, Dual Ma.
| Device ID | K002723 |
| 510k Number | K002723 |
| Device Name: | REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA |
| 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 | 2000-08-31 |
| Decision Date | 2000-09-28 |