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510(k) K922397

4 SURE TM NASAL OXYGEN CANNULA by Boston Pacific Medical, Inc. — Product Code CAT

K922397 is an FDA 510(k) premarket notification submitted by Boston Pacific Medical, Inc. for the device "4 SURE TM NASAL OXYGEN CANNULA". The FDA issued a decision of Substantially Equivalent on March 18, 1993. The device falls under product code CAT (Cannula, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5340. Boston Pacific Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1993
Date Received
May 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Nasal, Oxygen
Device Class
Class I
Regulation Number
868.5340
Review Panel
AN
Submission Type

Other clearances by Boston Pacific Medical, Inc.

  • K933109 — 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS (March 28, 1994)
  • K922402 — 4 SURE TM ENTERAL FEEDING BAG (March 25, 1994)
  • K931048 — 4-SURE NELATON CATHETER (February 14, 1994)
  • K931047 — 4-SURE FEMALE CATHETER (February 14, 1994)
  • K921852 — 4 SURE TM RECTAL TUBE (October 8, 1993)
  • K921853 — 4 SURE TM FEEDING TUBES (July 13, 1993)
  • K921851 — 4 SURE TM SUCTION CATHETERS & KITS (July 7, 1993)
  • K922398 — 4 SURE TM ENEMA BAG SET (June 17, 1993)
  • K924995 — 4 SURE TM ANESTHESIA EXTENSION SET (December 30, 1992)
  • K922401 — 4 SURE TM COLOSTOMY POUCH (June 10, 1992)

Other clearances for product code CAT

  • K011125 — NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA M (June 13, 2001)
  • K935533 — NASAL CANNULA (February 3, 1994)
  • K921496 — SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED (August 14, 1992)
  • K920573 — CANNULA NASAL OXYGEN (August 11, 1992)
  • K913421 — NASAL OXYGEN CANNULA, 81585, 81587 & 81589 (October 18, 1991)
  • K912197 — SKIN SAVER(TM) TUBING HOLDER, MODEL 467 (August 20, 1991)
  • K911740 — SALTER LABS NEONATAL NASAL OXYGEN CANNULA (July 24, 1991)
  • K902420 — CATHETER, NASAL, OXYGEN (April 17, 1991)
  • K896036 — THE COMFORTABLE CANNULA (November 17, 1989)
  • K892435 — KENDALL CURITY OXYGEN NASAL CANNULA (June 12, 1989)

FDA data resources