The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Cardiovascular Procedure Kit.
| Device ID | K212258 |
| 510k Number | K212258 |
| Device Name: | Medline Cardiovascular Procedure Kit |
| Classification | General Surgery Tray |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Stephanie Augsburg |
| Correspondent | Claire Pigman Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-07-20 |
| Decision Date | 2021-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00653160344356 | K212258 | 000 |
| 00653160259476 | K212258 | 000 |
| 00653160350067 | K212258 | 000 |
| 00653160362138 | K212258 | 000 |