The following data is part of a premarket notification filed by Interrad Medical, Inc. with the FDA for Modification To Securacath, Model: Spk01.
| Device ID | K083081 |
| 510k Number | K083081 |
| Device Name: | MODIFICATION TO SECURACATH, MODEL: SPK01 |
| Classification | Implanted Subcutaneous Securement Catheter |
| Applicant | INTERRAD MEDICAL, INC. 18555 37TH AVE N Plymouth, MN 55446 |
| Contact | Sew-wah Tay |
| Correspondent | Sew-wah Tay INTERRAD MEDICAL, INC. 18555 37TH AVE N Plymouth, MN 55446 |
| Product Code | OKC |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-16 |
| Decision Date | 2009-03-04 |
| Summary: | summary |