The following data is part of a premarket notification filed by Medcomp with the FDA for 1.9f X 20 Cm Vascu-picc, Models Vp1.9s20 And Vp1.9s50.
Device ID | K061986 |
510k Number | K061986 |
Device Name: | 1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50 |
Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
Contact | Susan Motzer |
Correspondent | Susan Motzer 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 | 2006-07-13 |
Decision Date | 2006-08-03 |
Summary: | summary |