The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore(r) Dryseal Sheath With Hydrophilic Coating.
| Device ID | K121234 |
| 510k Number | K121234 |
| Device Name: | GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING |
| Classification | Introducer, Catheter |
| Applicant | W. L. GORE & ASSOCIATES, INC. 3450 KILTIE LANE P.O. BOX 2400 Flagstaff, AZ 86003 -2400 |
| Contact | Alicia L Hemphill |
| Correspondent | Alicia L Hemphill W. L. GORE & ASSOCIATES, INC. 3450 KILTIE LANE P.O. BOX 2400 Flagstaff, AZ 86003 -2400 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-24 |
| Decision Date | 2012-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132620005 | K121234 | 000 |
| 00733132619993 | K121234 | 000 |
| 00733132619986 | K121234 | 000 |
| 00733132619979 | K121234 | 000 |
| 00733132619962 | K121234 | 000 |
| 00733132619955 | K121234 | 000 |
| 00733132619948 | K121234 | 000 |
| 00733132619931 | K121234 | 000 |