The following data is part of a premarket notification filed by Organ Recovery Systems, Inc. with the FDA for Lifeport, Kidney Perfusion Transporter (ktr).
| Device ID | K021362 |
| 510k Number | K021362 |
| Device Name: | LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) |
| Classification | System, Perfusion, Kidney |
| Applicant | ORGAN RECOVERY SYSTEMS, INC. 701 EAST BAY ST. SUITE 433 Charleston, SC 29403 |
| Contact | Stanley J Harris |
| Correspondent | Stanley J Harris ORGAN RECOVERY SYSTEMS, INC. 701 EAST BAY ST. SUITE 433 Charleston, SC 29403 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-30 |
| Decision Date | 2003-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815045020268 | K021362 | 000 |
| 00815045020018 | K021362 | 000 |
| 00815045020032 | K021362 | 000 |
| 00815045020049 | K021362 | 000 |
| 10815045020145 | K021362 | 000 |
| 10815045020084 | K021362 | 000 |
| 10815045020107 | K021362 | 000 |
| 10815045020121 | K021362 | 000 |
| 10815045020169 | K021362 | 000 |
| 10815045020183 | K021362 | 000 |
| 10815045020206 | K021362 | 000 |
| 20815045020241 | K021362 | 000 |
| 10815045020244 | K021362 | 000 |
| 00815045020001 | K021362 | 000 |