The following data is part of a premarket notification filed by Medcomp with the FDA for Pro-picc.
| Device ID | K091953 | 
| 510k Number | K091953 | 
| Device Name: | PRO-PICC | 
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days | 
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 | 
| Contact | Jean Callow | 
| Correspondent | Jean Callow MEDCOMP 1499 DELP DR. Harleysville, PA 19438 | 
| Product Code | LJS | 
| CFR Regulation Number | 880.5970 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2009-07-01 | 
| Decision Date | 2009-09-16 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  PRO-PICC  78646170  3276923 Live/Registered | Medical Components, Inc. 2005-06-08 |