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510(k) K850247

PERITONEAL DIALYSIS COIL CATHETER by Sil-Med Corp. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1985
Date Received
January 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
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 FXX

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  • K252830 — Disposable Surgical Face Mask (3P00B, C2900) (January 12, 2026)
  • K252650 — Disposable Medical Face Mask (January 5, 2026)
  • K243342 — KP Protective Face Mask (December 22, 2025)
  • K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (December 11, 2025)
  • K252964 — PRIMED Surgical and Procedure Masks (November 4, 2025)
  • K251902 — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with S (September 17, 2025)
  • K250082 — Procedure mask/Surgical mask/Face mask (June 18, 2025)
  • K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); (May 30, 2025)