SecurAcath
FDA 510(k) clearance K180769 · decided 2018-06-26
Clearance details
- K-number
- K180769
- Device name
- SecurAcath
- Applicant
- Interrad Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-03-23
- Decision date
- 2018-06-26
- Days to decision
- 95 days
- Clearance type
- Special
- Product code
- OKC
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SecurAcath (K210629) | Interrad Medical, Inc. | 2021-04-12 |
| SECURACATH (K120935) | Interrad Medical, Inc. | 2012-04-27 |
| MODIFICATION TO SECURACATH, MODEL: SPK01 (K083081) | Interrad Medical, Inc. | 2009-03-04 |
| SECURACATH CATHETER, MODEL SPK01 (K082047) | Interrad Medical, Inc. | 2008-09-30 |
Recalls involving this device
No recalls on record reference this clearance.