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510(k) K863446

ANGIOMED HIGH PRESSURE CONNECTORS by Angiomed U.S., Inc. — Product Code GCD

K863446 is an FDA 510(k) premarket notification submitted by Angiomed U.S., Inc. for the device "ANGIOMED HIGH PRESSURE CONNECTORS". The FDA issued a decision of Substantially Equivalent on September 23, 1986. The device falls under product code GCD (Connector, Catheter), a Class I device regulated under 21 CFR 878.4200. Angiomed U.S., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1986
Date Received
September 8, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Angiomed U.S., Inc.

  • K874771 — ANGIOMED INTRODUCING SETS (January 12, 1988)
  • K874585 — ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE (December 2, 1987)
  • K864225 — ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT (January 30, 1987)
  • K863386 — VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS (October 24, 1986)
  • K862805 — ANGIOMED VAC-U-CUT BIOPSY NEEDLE (September 29, 1986)
  • K854910 — ANGIOFLOW (July 17, 1986)
  • K854912 — ANGIOMED GUIED WIRES (April 16, 1986)
  • K854908 — UROFLEX (March 14, 1986)
  • K855143 — ANGIOMED EXCHANGE DRAINAGE CATHETER SETS (March 11, 1986)
  • K855076 — ANGIOMED URETER DIATION SETS (March 11, 1986)

Other clearances for product code GCD

  • K952470 — ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. (November 28, 1995)
  • K940198 — L-CATH CONNECTOR ASSEMBLY (December 15, 1994)
  • K851196 — INCISION DRAIN (June 4, 1985)
  • K851921 — Y CONNECTOR (May 17, 1985)
  • K760524 — CATHETER CONNECTOR, ARGYLE TUBING (November 2, 1976)
  • K760382 — CONNECTORS (November 2, 1976)
  • K760203 — TUBE, STERILE NON-CONDUCTIVE CONNECTING (July 19, 1976)

FDA data resources