The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Cerebase Da Guide Sheath, 95cm, Cerebase Da Guide Sheath, 90cm, Cerebase Da Guide Sheath, 80cm, Cerebase Da Guide Sheath, 70cm.
| Device ID | K192804 |
| 510k Number | K192804 |
| Device Name: | CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Medos International SARL Chemin-Blanc 38 Le Locle Neuchatel, CH 2400 |
| Contact | Michael Liao |
| Correspondent | Michael Liao Medos International SARL Chemin-Blanc 38 Le Locle Neuchatel, CH 2400 |
| Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-01 |
| Decision Date | 2020-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704082323 | K192804 | 000 |
| 10886704082316 | K192804 | 000 |
| 10886704082309 | K192804 | 000 |
| 10886704082293 | K192804 | 000 |