PATHWAY ACCESS SHEATH CATHETER
Dilator, Catheter, Ureteral
VERTELINK CORPORATION
The following data is part of a premarket notification filed by Vertelink Corporation with the FDA for Pathway Access Sheath Catheter.
Pre-market Notification Details
| Device ID | K030662 |
| 510k Number | K030662 |
| Device Name: | PATHWAY ACCESS SHEATH CATHETER |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | VERTELINK CORPORATION 27001 LA PAZ SUITE 312 Mission Viejo, CA 92691 |
| Contact | Albert Rego |
| Correspondent | Albert Rego VERTELINK CORPORATION 27001 LA PAZ SUITE 312 Mission Viejo, CA 92691 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-03 |
| Decision Date | 2003-09-03 |
Trademark Results [PATHWAY ACCESS SHEATH CATHETER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PATHWAY ACCESS SHEATH CATHETER 78304647 3399335 Dead/Cancelled |
Onset Medical Corporation 2003-09-24 |
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