The following data is part of a premarket notification filed by Keystone Heart, Ltd. with the FDA for Lim Precision Steerable Ts, Steerable Sheath, Dilator.
| Device ID | K202226 |
| 510k Number | K202226 |
| Device Name: | Lim Precision Steerable TS, Steerable Sheath, Dilator |
| Classification | Introducer, Catheter |
| Applicant | Keystone Heart, Ltd. 15 Halamish Street, PO Box 3170 Caesaria, IL 3088900 |
| Contact | Jaime Sarabia |
| Correspondent | Mike Winegar Winegar Consulting, Inc. 7829 Ithaca Ln N Maple Grove, MN 55311 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-07 |
| Decision Date | 2020-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850020653003 | K202226 | 000 |