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510(k) K951533

EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT by Ballard Medical Products — Product Code KDH

K951533 is an FDA 510(k) premarket notification submitted by Ballard Medical Products for the device "EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT". The FDA issued a decision of Substantially Equivalent on July 5, 1995. The device falls under product code KDH (Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration), a Class II device regulated under 21 CFR 876.5980. Ballard Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1995
Date Received
April 3, 1995
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 Ballard Medical Products

  • K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (March 31, 2003)
  • K022398 — REUSABLE BRONCHIAL BIOPSY FORCEPS (October 11, 2002)
  • K013892 — LUTZ NEEDLE (July 11, 2002)
  • K000495 — BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES (March 28, 2000)
  • K993138 — BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT (October 20, 1999)
  • K990376 — BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME (May 3, 1999)
  • K982894 — MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT (September 11, 1998)
  • K974630 — 72 HOUR USE TRACH CARE WITH MICROBAN (March 11, 1998)
  • K964369 — TRACH CARE SET WITH MICROBAN (February 11, 1997)
  • K923487 — BAL CATH (July 30, 1993)

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)
  • 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)
  • K914908 — QUICVAGE PLUS (April 13, 1992)
  • K914907 — QUICVAGE (January 24, 1992)
  • K911788 — ECONOVAGE R (July 26, 1991)

FDA data resources