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510(k) K830326

NEGATIVE PRESSURE ARTERIAL BLOOD LINE by Erika, Inc. — Product Code KDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1983
Date Received
February 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Erika, Inc.

  • K853134 — NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 (November 6, 1985)
  • K852310 — NATURALYTE BICARBONATE CONCENTRATE-DRY PACK (July 26, 1985)
  • K852309 — ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 (July 26, 1985)
  • K850865 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- (April 3, 1985)
  • K850866 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L (April 3, 1985)
  • K850655 — TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 (March 7, 1985)
  • K850654 — TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID (March 7, 1985)
  • K842436 — ERIKA NEGATIVE PRESS. ARTERIAL BLOOD (July 13, 1984)
  • K831173 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER (June 22, 1984)
  • K831174 — FILTRYZER HOLLOW FIBER ARTIFICIAL KID- (June 22, 1984)

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  • K920263 — MANUAL SURGICAL INSTRUMENTS (May 6, 1992)
  • K915064 — DISPOSABLE CAUTERY ABRASIVE PAD (March 11, 1992)
  • K914960 — INSTRUMENT ORGANIZER (February 28, 1992)
  • K912834 — SHUR-GRIP (July 26, 1991)
  • K910079 — DISPOSABLE INTRODUCER SHEATH (February 27, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K903649 — BRADLEY TENACULUM HOLDER (November 2, 1990)