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510(k) K051805

KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE by Tyco Healthcare/Kendall — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2005
Date Received
July 5, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

Other clearances by Tyco Healthcare/Kendall

  • K060339 — KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERIL (April 28, 2006)
  • K040511 — SCD EXPRESS PORTABLE COMPRESSION SYSTEM (June 28, 2004)
  • K040196 — KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS (May 5, 2004)

Other clearances for product code JOW

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  • K250974 — Bio Arterial Deluxe (IC-BAP-DX) (December 12, 2025)
  • K250190 — Sequential Compression System (SCD600) (December 8, 2025)
  • K251466 — VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compressio (October 28, 2025)
  • K251446 — PlasmaFlow X Compression Sleeve Device (XPF0001) (September 17, 2025)
  • K251086 — PnueAira (PNCU-01) (August 18, 2025)
  • K250817 — Coretech Compression System (Coretech RHB3003) (August 8, 2025)
  • K241096 — Venera 608 Deep Vein Thrombosis (DVT) Prevention System (January 15, 2025)
  • K240499 — ARTAIRA Arterial Compression Device (AACD01) (October 11, 2024)
  • K241746 — UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRES (October 4, 2024)