The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Epiducer Lead Delivery System.
| Device ID | K110609 |
| 510k Number | K110609 |
| Device Name: | EPIDUCER LEAD DELIVERY SYSTEM |
| Classification | Electrode, Spinal Epidural |
| Applicant | ST. JUDE MEDICAL 6901 PRESTON ROAD Plano, TX 75024 |
| Contact | Rashmi Moza |
| Correspondent | Rashmi Moza ST. JUDE MEDICAL 6901 PRESTON ROAD Plano, TX 75024 |
| Product Code | LHG |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-03 |
| Decision Date | 2011-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734403962 | K110609 | 000 |
| 05414734403955 | K110609 | 000 |
| 05414734401357 | K110609 | 000 |
| 15414734400142 | K110609 | 000 |