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510(k) K870196

PCTE MICROPOROUS MEMBRANE FILTER by Poretics Corp. — Product Code KET

K870196 is an FDA 510(k) premarket notification submitted by Poretics Corp. for the device "PCTE MICROPOROUS MEMBRANE FILTER". The FDA issued a decision of Substantially Equivalent on May 12, 1987. The device falls under product code KET (Filters, Cell Collection, Tissue Processing), a Class I device regulated under 21 CFR 864.3010.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1987
Date Received
January 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filters, Cell Collection, Tissue Processing
Device Class
Class I
Regulation Number
864.3010
Review Panel
PA
Submission Type

Other clearances for product code KET

  • K875122 — DISPOSABLE STERILE SYRINGE FILTERS (January 12, 1988)
  • K844671 — CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON (February 25, 1985)
  • K840556 — DISPOSABLE SYRINGE FILTERS (March 5, 1984)
  • K792633 — STERILIZATION PROCESS/OUTERWRAP (January 11, 1980)

FDA data resources