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510(k) K914908

QUICVAGE PLUS by Autovage — Product Code KDH

K914908 is an FDA 510(k) premarket notification submitted by Autovage for the device "QUICVAGE PLUS". The FDA issued a decision of Substantially Equivalent (kit) on April 13, 1992. The device falls under product code KDH (Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration), a Class II device regulated under 21 CFR 876.5980. Autovage has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 13, 1992
Date Received
November 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Autovage

  • K922785 — IRRIVAGE (October 16, 1992)
  • K914907 — QUICVAGE (January 24, 1992)
  • K911788 — ECONOVAGE R (July 26, 1991)
  • K911919 — MINIVAGE(R) (July 26, 1991)
  • K840943 — ENDO-JECT (May 25, 1984)
  • K823195 — GASTRIC LAVAGE KIT (December 3, 1982)

Other clearances for product code KDH

  • K983624 — GILTECH PLUS CONNECTING TUBE SET (March 18, 1999)
  • K981286 — SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS (June 19, 1998)
  • K971259 — COMBIPORT FLUID LAVAGE DEVICE (October 27, 1997)
  • K962850 — TUM-E-VAC (February 21, 1997)
  • K951533 — EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (July 5, 1995)
  • K923497 — FLUSHING IRRIGATION SET (March 21, 1994)
  • K920527 — TRI-MED QUICK-STEP GASTRIC LAVAGE KIT (September 4, 1992)
  • K920619 — TRI-MED GASTRIC LAVAGE SYSTEM (September 4, 1992)
  • K914907 — QUICVAGE (January 24, 1992)
  • K911788 — ECONOVAGE R (July 26, 1991)

FDA data resources