The following data is part of a premarket notification filed by Merck Millipore Ltd. with the FDA for Cathivex ¿gv Filter Units.
| Device ID | K143583 |
| 510k Number | K143583 |
| Device Name: | Cathivex ¿GV Filter Units |
| Classification | Filter, Infusion Line |
| Applicant | MERCK MILLIPORE LTD. TULLAGREEN Carrigtwohill, IE Ei |
| Contact | Chris Parr |
| Correspondent | Chris Parr MERCK MILLIPORE LTD. TULLAGREEN Carrigtwohill, IE Ei |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-18 |
| Decision Date | 2015-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04054839076541 | K143583 | 000 |