The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Cadence Precision Injector, Model 103-0304.
| Device ID | K011535 |
| 510k Number | K011535 |
| Device Name: | CADENCE PRECISION INJECTOR, MODEL 103-0304 |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Contact | Eben Gordon |
| Correspondent | Eben Gordon MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-18 |
| Decision Date | 2001-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00836462006010 | K011535 | 000 |