The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Micro Therapeutics Variable Infusion Length Catheter.
| Device ID | K953335 |
| 510k Number | K953335 |
| Device Name: | MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MICRO THERAPEUTICS, INC. 27412-B LAGUNA HILLS DR. Aliso Viejo, CA 92656 |
| Contact | Linda D'abate |
| Correspondent | Linda D'abate MICRO THERAPEUTICS, INC. 27412-B LAGUNA HILLS DR. Aliso Viejo, CA 92656 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-17 |
| Decision Date | 1996-01-23 |