510(k) K120935
- Device
- SECURACATH
- Applicant
- INTERRAD MEDICAL INC
- 510(k) number
- K120935
- Product code
- OKC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-04-27
- Date received
- 2012-03-28
- Regulation
- 880.5970
- Classification name
- Implanted Subcutaneous Securement Catheter
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sew-Wah Tay
- Address
- 8401 73rd Ave. N. Suite 63 Minneapolis MN US 55428 55428
FDA Registration Numbers#
- 2183744
- 3007795799
Source Documents#
Other 510(k) Records For Product Code OKC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210629 | SecurAcath | Interrad Medical, Inc. | 2021-04-12 |
| K180769 | SecurAcath | Interrad Medical, Inc. | 2018-06-26 |
| K083081 | MODIFICATION TO SECURACATH, MODEL: SPK01 | Interrad Medical, Inc. | 2009-03-04 |
| K082047 | SECURACATH CATHETER, MODEL SPK01 | Interrad Medical, Inc. | 2008-09-30 |
Legacy Summary#
summary
FDA Review#
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