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 |