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510(k) K843575

DERBYSHIRE DRAIN by Sil-Med Corp. — Product Code GBW

K843575 is an FDA 510(k) premarket notification submitted by Sil-Med Corp. for the device "DERBYSHIRE DRAIN". The FDA issued a decision of Substantially Equivalent on October 24, 1984. The device falls under product code GBW (Catheter, Peritoneal), 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
October 24, 1984
Date Received
September 11, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peritoneal
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)
  • K926408 — SIL-SLIP FLAT SUCTION DRAIN (February 2, 1994)
  • K926495 — SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE (February 2, 1994)

Other clearances for product code GBW

  • K992904 — MINI-PORT (October 5, 1999)
  • K992907 — INTRADUCER (October 5, 1999)
  • K972112 — INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 (December 1, 1997)
  • K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN (August 8, 1996)
  • K960426 — MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER (March 21, 1996)
  • K942709 — MEDIASTINAL SILICONE DRAINS (January 4, 1996)
  • K933510 — ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER (February 24, 1994)
  • K926477 — BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO (November 12, 1993)
  • K913733 — STERILE CHEST TUBE (October 8, 1991)
  • K894220 — HOUTS HYSTERECTOMY DRAIN (August 24, 1989)

FDA data resources