510(k) K210629
- Device
- SecurAcath
- Applicant
- Interrad Medical, Inc.
- 510(k) number
- K210629
- Product code
- OKC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-04-12
- Date received
- 2021-03-02
- 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
- Denise Lenz
- Address
- 181 Cheshire Ln., Suite 100 Plymouth MN US 55441 55441
FDA Registration Numbers#
- 3007795799
- 2183744
Source Documents#
Other 510(k) Records For Product Code OKC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K180769 | SecurAcath | Interrad Medical, Inc. | 2018-06-26 |
| K120935 | SECURACATH | Interrad Medical, Inc. | 2012-04-27 |
| K083081 | MODIFICATION TO SECURACATH, MODEL: SPK01 | Interrad Medical, Inc. | 2009-03-04 |
| K082047 | SECURACATH CATHETER, MODEL SPK01 | Interrad Medical, Inc. | 2008-09-30 |