The following data is part of a premarket notification filed by Norfolk Medical with the FDA for Norcath Vascular Access Catheters.
| Device ID | K911067 |
| 510k Number | K911067 |
| Device Name: | NORCATH VASCULAR ACCESS CATHETERS |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | NORFOLK MEDICAL 7307 N. RIDGEWAY Skokie, IL 60076 |
| Contact | Michael J Dalton |
| Correspondent | Michael J Dalton NORFOLK MEDICAL 7307 N. RIDGEWAY Skokie, IL 60076 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-11 |
| Decision Date | 1991-06-03 |