The following data is part of a premarket notification filed by Mediplus Ltd. with the FDA for Suprapubic Catheter And Introducer Set.
| Device ID | K132890 |
| 510k Number | K132890 |
| Device Name: | SUPRAPUBIC CATHETER AND INTRODUCER SET |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | MEDIPLUS LTD. UNIT 7, THE GATEWAY CENTRE CORONATION RD, CRESSEX BUS. PK. High Wycombe, Bucks, GB Hp12 35u |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden MEDIPLUS LTD. UNIT 7, THE GATEWAY CENTRE CORONATION RD, CRESSEX BUS. PK. High Wycombe, Bucks, GB Hp12 35u |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-16 |
| Decision Date | 2014-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15055140702262 | K132890 | 000 |
| 15055140700107 | K132890 | 000 |
| 15055140700114 | K132890 | 000 |
| 15055140701197 | K132890 | 000 |
| 15055140701203 | K132890 | 000 |
| 15055140701210 | K132890 | 000 |
| 15055140701227 | K132890 | 000 |
| 15055140701333 | K132890 | 000 |
| 15055140701340 | K132890 | 000 |
| 15055140701609 | K132890 | 000 |
| 15055140702231 | K132890 | 000 |
| 15055140700091 | K132890 | 000 |