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510(k) K840201

EPIDURAL CATHETER TRAY by Aries Medical, Inc. — Product Code MJL

K840201 is an FDA 510(k) premarket notification submitted by Aries Medical, Inc. for the device "EPIDURAL CATHETER TRAY". The FDA issued a decision of Substantially Equivalent on March 2, 1984. The device falls under product code MJL (Eia, Blastomyces Dermatitidis), a Class II device regulated under 21 CFR 866.3060. Aries Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1984
Date Received
January 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Eia, Blastomyces Dermatitidis
Device Class
Class II
Regulation Number
866.3060
Review Panel
MI
Submission Type

Other clearances by Aries Medical, Inc.

  • K912604 — SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF (October 28, 1991)
  • K903925 — ARIES MELDICAL MODEL 2100HC HANK CRANK (December 21, 1990)
  • K903442 — ARIES TAPERSEAL(TM) SHEATH (August 23, 1990)
  • K895433 — ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS (April 10, 1990)
  • K882289 — ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. (December 12, 1988)
  • K864994 — 40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER (June 19, 1987)
  • K864537 — 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER (June 19, 1987)
  • K864568 — 40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER (May 12, 1987)
  • K864567 — 40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER (May 12, 1987)
  • K871140 — ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER (April 22, 1987)

Other clearances for product code MJL

  • K923859 — PREMIER BLASTOMYCES (October 5, 1992)

FDA data resources