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 |
10815045020565 | K021362 | 000 |
10815045020473 | K021362 | 000 |
10815045020459 | K021362 | 000 |
10815045020435 | K021362 | 000 |
00815045020391 | K021362 | 000 |
00815045020377 | K021362 | 000 |
10815045020336 | K021362 | 000 |
10815045020312 | K021362 | 000 |
10815045020275 | K021362 | 000 |
10815045020251 | K021362 | 000 |
00815045020001 | K021362 | 000 |
00815045020018 | K021362 | 000 |
00815045020032 | K021362 | 000 |
10815045020244 | K021362 | 000 |
20815045020241 | K021362 | 000 |
10815045020206 | K021362 | 000 |
10815045020183 | K021362 | 000 |
10815045020169 | K021362 | 000 |
10815045020121 | K021362 | 000 |
10815045020107 | K021362 | 000 |
10815045020084 | K021362 | 000 |
10815045020145 | K021362 | 000 |
00815045020049 | K021362 | 000 |
10815045020237 | K021362 | 000 |