The following data is part of a premarket notification filed by Rita Medical Systems, Inc. with the FDA for Vortex Ct Port Access System And Lifeguard Safety Infusion Set.
| Device ID | K062414 |
| 510k Number | K062414 |
| Device Name: | VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | RITA MEDICAL SYSTEMS, INC. ONE HORIZON WAY Manchester, GA 31816 |
| Contact | David Smith |
| Correspondent | David Smith RITA MEDICAL SYSTEMS, INC. ONE HORIZON WAY Manchester, GA 31816 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-17 |
| Decision Date | 2007-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787CT96STSDVI1 | K062414 | 000 |
| H787CT75STSA0 | K062414 | 000 |
| H787CT75STSD0 | K062414 | 000 |
| H787CT75STSDNF0 | K062414 | 000 |
| H787CT75STSDNFVI1 | K062414 | 000 |
| H787CT75STSDVI1 | K062414 | 000 |
| H787CT80STPA0 | K062414 | 000 |
| H787CT80STPAVI1 | K062414 | 000 |
| H787CT80STPD0 | K062414 | 000 |
| H787CT80STPDNF0 | K062414 | 000 |
| H787CT80STPDNFVI1 | K062414 | 000 |
| H787CT80STPDVI1 | K062414 | 000 |
| H787CT96STSA0 | K062414 | 000 |
| H787CT96STSAVI1 | K062414 | 000 |
| H787CT96STSD0 | K062414 | 000 |
| H787CT96STSDNF0 | K062414 | 000 |
| H787CT96STSDNFVI1 | K062414 | 000 |
| H787CT75STSAVI1 | K062414 | 000 |