The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Rebar Micro Catheter, Models 105-5080, 105-5086.
Device ID | K993672 |
510k Number | K993672 |
Device Name: | REBAR MICRO CATHETER, MODELS 105-5080, 105-5086 |
Classification | Catheter, Continuous Flush |
Applicant | MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
Contact | Tom Daughters |
Correspondent | Tom Daughters 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 | 1999-11-01 |
Decision Date | 2000-01-04 |
Summary: | summary |