Home / 510(k) Clearances / K843257

510(k) K843257

ANGIO SYS STERILE FIELD COVER by Angiosystems, Inc.

K843257 is an FDA 510(k) premarket notification submitted by Angiosystems, Inc. for the device "ANGIO SYS STERILE FIELD COVER". The FDA issued a decision of Substantially Equivalent on September 21, 1984. Angiosystems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1984
Date Received
August 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Angiosystems, Inc.

  • K905464 — MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING (May 31, 1991)
  • K905459 — SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM (April 5, 1991)
  • K905461 — PROCEDURE KIT/ROUTINE DENTAL PROCEDURES (March 5, 1991)
  • K905466 — STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE (February 11, 1991)
  • K905465 — STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE (February 11, 1991)
  • K905460 — STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY (February 6, 1991)
  • K905462 — PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES (February 6, 1991)
  • K905463 — GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION (January 22, 1991)
  • K864688 — ARNOLD-KING PRESSURE DRESSING (January 12, 1987)
  • K843259 — ANGIO SYS FLUOROSCOPE DRAPE (September 21, 1984)

FDA data resources