The following data is part of a premarket notification filed by Vascutek Ltd. with the FDA for Gelsoft Plus Ers.
| Device ID | K034010 |
| 510k Number | K034010 |
| Device Name: | GELSOFT PLUS ERS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | VASCUTEK LTD. 6200 JACKSON RD. Ann Arbor, MI 48103 -9300 |
| Contact | Steven Arick |
| Correspondent | Steven Arick VASCUTEK LTD. 6200 JACKSON RD. Ann Arbor, MI 48103 -9300 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-24 |
| Decision Date | 2004-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881998497 | K034010 | 000 |
| 05037881115696 | K034010 | 000 |
| 05037881115689 | K034010 | 000 |
| 05037881115672 | K034010 | 000 |
| 05037881115665 | K034010 | 000 |
| 05037881020181 | K034010 | 000 |
| 05037881020174 | K034010 | 000 |
| 05037881020136 | K034010 | 000 |
| 05037881020051 | K034010 | 000 |
| 05037881115702 | K034010 | 000 |
| 05037881115719 | K034010 | 000 |
| 05037881115726 | K034010 | 000 |
| 05037881115801 | K034010 | 000 |
| 05037881115795 | K034010 | 000 |
| 05037881115788 | K034010 | 000 |
| 05037881115771 | K034010 | 000 |
| 05037881115764 | K034010 | 000 |
| 05037881115757 | K034010 | 000 |
| 05037881115740 | K034010 | 000 |
| 05037881115733 | K034010 | 000 |
| 05037881020044 | K034010 | 000 |