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510(k) K843261

ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD by Angiosystems, Inc. — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1984
Date Received
August 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
Submission Type

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)
  • K905465 — STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE (February 11, 1991)
  • K905466 — STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL 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)

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  • K241720 — VersaCross Connect™ Transseptal Dilator (July 12, 2024)
  • K233647 — VersaCross Connect™ Transseptal Dilator (December 14, 2023)
  • K232609 — Micro Ace™ Advanced Micro Access System (September 27, 2023)
  • K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guard (December 15, 2022)
  • K212784 — TightRail Guardian Motorized Dilator Sheath (August 24, 2022)
  • K211679 — Xtractor device (February 17, 2022)
  • K210734 — Endovascular Dilator and Sets (April 6, 2021)