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510(k) K905614

JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS by Baxter Healthcare Corp — Product Code GBX

K905614 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS". The FDA issued a decision of Substantially Equivalent on Mar 20, 1991. The device falls under product code GBX (Catheter, Irrigation), a Class I device regulated under 21 CFR 878.4200. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 20, 1991
Date Received
Dec 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Catheter, Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type
510(k) Exempt

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Other clearances for product code GBX

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  • K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (Oct 21, 2005)
  • K043515 — GRAFTSAVER (Mar 31, 2005)
  • K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P (Jan 10, 2002)
  • K000704 — DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (May 19, 2000)
  • K974233 — LYSONIX IRRIGATION SYSTEM (Feb 3, 1998)
  • K973703 — JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (Dec 4, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (Oct 1, 1997)
  • K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR (Mar 10, 1997)

FDA data resources

Source: FDA 510(k) database entry for K905614. Report a data issue: hello@regdatalab.com.