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 |