TidalPort-AP Implantable Apheresis Vascular Access Port
FDA 510(k) clearance K192291 · decided 2020-08-20
Clearance details
- K-number
- K192291
- Device name
- TidalPort-AP Implantable Apheresis Vascular Access Port
- Applicant
- Norfolk Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-08-23
- Decision date
- 2020-08-20
- Days to decision
- 363 days
- Clearance type
- Traditional
- Product code
- PTD
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Skokie, IL, 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 |
|---|---|---|
| PowerFlow Implantable Apheresis IV Port (K191143) | C.R. Bard, Inc. | 2019-08-02 |
| PowerFlow Apheresis I.V. Port (K163001) | C.R. Bard, Inc. | 2017-04-17 |
Recalls involving this device
No recalls on record reference this clearance.