PCTE MICROPOROUS MEMBRANE FILTER
FDA 510(k) clearance K870196 · decided 1987-05-12
Clearance details
- K-number
- K870196
- Device name
- PCTE MICROPOROUS MEMBRANE FILTER
- Applicant
- Poretics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-01-20
- Decision date
- 1987-05-12
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- KET
- Device class
- 1
- Regulation number
- 864.3010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Livermore, CA, 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 |
|---|---|---|
| DISPOSABLE STERILE SYRINGE FILTERS (K875122) | Corning Medical & Scientific | 1988-01-12 |
| CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON (K844671) | Corning Medical & Scientific | 1985-02-25 |
| DISPOSABLE SYRINGE FILTERS (K840556) | Corning Medical & Scientific | 1984-03-05 |
| STERILIZATION PROCESS/OUTERWRAP (K792633) | Procter & Gamble Mfg. Co. | 1980-01-11 |
Recalls involving this device
No recalls on record reference this clearance.