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510(k) K904488

KALTOSTAT WOUND DRESSING by Calgon Vestal Div. — Product Code QSY

K904488 is an FDA 510(k) premarket notification submitted by Calgon Vestal Div. for the device "KALTOSTAT WOUND DRESSING". The FDA issued a decision of SN on December 12, 1990. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Calgon Vestal Div. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
December 12, 1990
Date Received
October 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

To temporarily control bleeding and cover external wounds.

Other clearances by Calgon Vestal Div.

  • K944494 — ALSA-KLENZ (October 19, 1994)
  • K944033 — BILL EVANS-KLENZ (October 7, 1994)
  • K942270 — SAF-GEL HYDRATING DERMAL WOUND DRESSING (August 4, 1994)
  • K931477 — AMERSE (June 17, 1994)
  • K931342 — LPH (May 26, 1994)
  • K931816 — VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM (May 26, 1994)
  • K941163 — MON-KLENZ (May 18, 1994)
  • K931573 — VESPHENE II (May 16, 1994)
  • K932277 — LONZA FORMULATION R-82 (May 12, 1994)
  • K931599 — HYDRASORB STERILE DRESSING (July 8, 1993)

Other clearances for product code QSY

  • K253017 — BloodSTOP iX Trauma Matrix (TM-iX-20) (April 30, 2026)
  • K251700 — Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x (February 26, 2026)
  • K250319 — MFUSE (MS001) (December 15, 2025)
  • K253609 — TRAUMAGEL® 2.0 Hemostatic Gel (December 12, 2025)
  • K240713 — TRAUMAGEL® (August 14, 2024)
  • K240097 — Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) (May 22, 2024)
  • K232216 — Hemoblock_S (Prescription); Hemoblock_S (OTC) (April 19, 2024)
  • K240454 — RESPONDER® Polysaccharide Hemostat (March 15, 2024)
  • K220525 — RESPONDER Polysaccharide Hemostat (December 4, 2023)
  • K230589 — Celox Rapid X-Ray Gauze (November 17, 2023)

FDA data resources