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510(k) K851921

Y CONNECTOR by Sil-Med Corp. — Product Code GCD

K851921 is an FDA 510(k) premarket notification submitted by Sil-Med Corp. for the device "Y CONNECTOR". The FDA issued a decision of Substantially Equivalent on May 17, 1985. The device falls under product code GCD (Connector, Catheter), a Class I device regulated under 21 CFR 878.4200. Sil-Med Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1985
Date Received
May 2, 1985
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 Sil-Med Corp.

  • K972521 — NAVIGATOR (STYLET) 2006 (October 1, 1997)
  • K961392 — ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II (July 18, 1997)
  • K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN (August 8, 1996)
  • K961295 — SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR (June 26, 1996)
  • K960099 — PENROSE DRAIN MODELS 6001 - 6007 (March 11, 1996)
  • K955463 — GRIP-A-BOOTS (January 23, 1996)
  • K942709 — MEDIASTINAL SILICONE DRAINS (January 4, 1996)
  • K926496 — SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN (May 24, 1995)
  • K926495 — SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE (February 2, 1994)
  • K926408 — SIL-SLIP FLAT SUCTION DRAIN (February 2, 1994)

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)
  • K863446 — ANGIOMED HIGH PRESSURE CONNECTORS (September 23, 1986)
  • K851196 — INCISION DRAIN (June 4, 1985)
  • K760382 — CONNECTORS (November 2, 1976)
  • K760524 — CATHETER CONNECTOR, ARGYLE TUBING (November 2, 1976)
  • K760203 — TUBE, STERILE NON-CONDUCTIVE CONNECTING (July 19, 1976)

FDA data resources