The following data is part of a premarket notification filed by Facile Medical, Inc. with the FDA for Sheath-in-sheath Catheter, 18fr, Model S00018; Sheath-in-sheath Catheter, 6 Fr., Model S00019.
| Device ID | K042308 |
| 510k Number | K042308 |
| Device Name: | SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019 |
| Classification | Introducer, Catheter |
| Applicant | FACILE MEDICAL, INC. 27001 LA PAZ SUITE 312 Mission Viejo, CA 92691 |
| Contact | Albert Rego |
| Correspondent | Albert Rego FACILE MEDICAL, INC. 27001 LA PAZ SUITE 312 Mission Viejo, CA 92691 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-25 |
| Decision Date | 2005-02-17 |
| Summary: | summary |