The following data is part of a premarket notification filed by Medical Components Inc with the FDA for Ps X Series (basic Components And Catheter), Pd X Series (catheter With All Components).
| Device ID | K121383 |
| 510k Number | K121383 |
| Device Name: | PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | MEDICAL COMPONENTS INC 1499 DELP DRIVE Harleysville, PA 19438 |
| Contact | Jean Callow |
| Correspondent | Jean Callow MEDICAL COMPONENTS INC 1499 DELP DRIVE Harleysville, PA 19438 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-08 |
| Decision Date | 2012-09-05 |
| Summary: | summary |