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510(k) K972969

QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM by Innovative Medical Technologies, Inc. — Product Code GIO

K972969 is an FDA 510(k) premarket notification submitted by Innovative Medical Technologies, Inc. for the device "QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 22, 1997. The device falls under product code GIO (Tube, Collection, Capillary Blood), a Class I device regulated under 21 CFR 864.6150. Innovative Medical Technologies, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1997
Date Received
August 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Collection, Capillary Blood
Device Class
Class I
Regulation Number
864.6150
Review Panel
HE
Submission Type

Other clearances by Innovative Medical Technologies, Inc.

  • K220458 — UltraFlo-R Push Button Blood Collection Set (September 29, 2023)
  • K123987 — IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET (August 27, 2013)
  • K936087 — CARPAL BOX (October 20, 1994)
  • K904237 — RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM (May 9, 1991)
  • K854194 — IMT ULTRASONIC STRIDE MONITOR (May 2, 1986)

Other clearances for product code GIO

  • K941291 — MONOJECT SAMPLETTE SEPARATOR TUBE (October 27, 1994)
  • K894851 — TRU-TRAX (September 29, 1989)
  • K885324 — HEMA(PRO)TEC(TION) (February 17, 1989)
  • K885138 — CAPILLARY TUBE, BLOOD COLLECTION (February 7, 1989)
  • K884623 — SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE (December 1, 1988)
  • K881262 — CARAWAY TUBES, HEPARIN AND PLAIN (May 6, 1988)
  • K881187 — NATELSON TUBES, HEPARIN AND PLAIN (May 6, 1988)
  • K875061 — MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR (January 12, 1988)
  • K873647 — VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE (October 20, 1987)
  • K850806 — CORNING BLOOD COLLECTION CAPILLARY TUBES (March 25, 1985)

FDA data resources