The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Proport Plastic Venous Implantable Access Systems Pre-assembled With Silicone Catheter.
Device ID | K010426 |
510k Number | K010426 |
Device Name: | PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Contact | Lisa J Stone |
Correspondent | Lisa J Stone SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Product Code | LJT |
CFR Regulation Number | 880.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-02-13 |
Decision Date | 2001-03-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00610586012627 | K010426 | 000 |
10610586012860 | K010426 | 000 |
10610586012846 | K010426 | 000 |
10610586012600 | K010426 | 000 |