The following data is part of a premarket notification filed by Medical Components Inc. (dba Medcomp) with the FDA for Symetrex Lthd Catheter, Symetrex Lthd Catheter With Sideholes.
| Device ID | K202176 |
| 510k Number | K202176 |
| Device Name: | Symetrex LTHD Catheter, Symetrex LTHD Catheter With Sideholes |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | Medical Components Inc. (Dba Medcomp) 1499 Delp Drive Harleysville, PA 19438 |
| Contact | Courtney Nix |
| Correspondent | Courtney Nix Medical Components Inc. (Dba Medcomp) 1499 Delp Drive Harleysville, PA 19438 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-04 |
| Decision Date | 2020-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50884908157012 | K202176 | 000 |
| 50884908156817 | K202176 | 000 |
| 50884908156800 | K202176 | 000 |
| 50884908156794 | K202176 | 000 |
| 50884908156787 | K202176 | 000 |
| 50884908156770 | K202176 | 000 |
| 50884908156763 | K202176 | 000 |
| 50884908156756 | K202176 | 000 |
| 50884908156701 | K202176 | 000 |
| 50884908156695 | K202176 | 000 |
| 50884908156640 | K202176 | 000 |
| 50884908156633 | K202176 | 000 |
| 50884908156589 | K202176 | 000 |
| 50884908156572 | K202176 | 000 |
| 50884908146764 | K202176 | 000 |
| 50884908146757 | K202176 | 000 |
| 50884908146658 | K202176 | 000 |
| 50884908156824 | K202176 | 000 |
| 50884908156831 | K202176 | 000 |
| 50884908157005 | K202176 | 000 |
| 50884908156992 | K202176 | 000 |
| 50884908157036 | K202176 | 000 |
| 50884908157029 | K202176 | 000 |
| 50884908156985 | K202176 | 000 |
| 50884908156954 | K202176 | 000 |
| 50884908156916 | K202176 | 000 |
| 50884908157111 | K202176 | 000 |
| 50884908157104 | K202176 | 000 |
| 50884908157098 | K202176 | 000 |
| 50884908157081 | K202176 | 000 |
| 50884908157074 | K202176 | 000 |
| 50884908157067 | K202176 | 000 |
| 50884908157050 | K202176 | 000 |
| 50884908157043 | K202176 | 000 |
| 50884908156848 | K202176 | 000 |
| 50884908146641 | K202176 | 000 |