The following data is part of a premarket notification filed by Jtl Medical Corp. with the FDA for Vacuum-assisted Blood Collection System.
| Device ID | K905818 |
| 510k Number | K905818 |
| Device Name: | VACUUM-ASSISTED BLOOD COLLECTION SYSTEM |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | JTL MEDICAL CORP. 3410-F LA SIERRA SUITE 208 Riverside, CA 92503 |
| Contact | James Lichte |
| Correspondent | James Lichte JTL MEDICAL CORP. 3410-F LA SIERRA SUITE 208 Riverside, CA 92503 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-31 |
| Decision Date | 1991-06-06 |