PT HEPARIN ADSORBENT
FDA 510(k) clearance K870771 · decided 1987-04-23
Clearance details
- K-number
- K870771
- Device name
- PT HEPARIN ADSORBENT
- Applicant
- Probe-Tek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-02-26
- Decision date
- 1987-04-23
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- JPA
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Lansing, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Inotech brand Heparin Adsorbant, Catalog #: HA-1, in 10mm x 75mm polystyrene tubes, each c recall (Z-0934-2008) | Inotech Biosystems Intl., Inc | 2008-02-07 |