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510(k) K802185

ARTERIAL BLOOD SAMPLING KIT by Current Technologies, Inc. — Product Code FMP

K802185 is an FDA 510(k) premarket notification submitted by Current Technologies, Inc. for the device "ARTERIAL BLOOD SAMPLING KIT". The FDA issued a decision of Substantially Equivalent on October 10, 1980. The device falls under product code FMP (Protector, Skin Pressure), a Class I device regulated under 21 CFR 880.6450. Current Technologies, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
September 10, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Skin Pressure
Device Class
Class I
Regulation Number
880.6450
Review Panel
HO
Submission Type

Other clearances by Current Technologies, Inc.

  • K833312 — ARTERIAL MICRO COLLECTION KIT (December 8, 1983)
  • K810816 — PREFILLED ARTERIAL BLOOD SAMPLING SYRING (April 7, 1981)

Other clearances for product code FMP

  • K150243 — Invictus Medical GelShield (May 1, 2015)
  • K951325 — COMFEEL PLUS PRESSURE RELIEF DRESSING (July 31, 1995)
  • K934731 — MEDSURG STERILE IMAGING PRODUCTS (March 28, 1994)
  • K820584 — DECUBICARE PADS & ACCESSORIES (March 25, 1982)
  • K812344 — HEEL OR ELBOW PROTECTOR (September 11, 1981)
  • K811184 — SPENCO DERMAL PADS (May 20, 1981)
  • K802829 — SCANLAN VASCU-STATT (January 15, 1981)
  • K801694 — FLOTATION PAD FOR OPERATING TABLE (August 27, 1980)
  • K801195 — DERMALEX OR NATRAWOOL SKIN PRESSURE PROT (June 9, 1980)
  • K792297 — SPAN AIDS KIT (December 20, 1979)

FDA data resources