Placement-Plus

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K003642 ↗

FDA Product Code

LJS

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Pasv Dual Lumen Peripherally Inserted Midline Catheter Model Number Midline-Numerous

  Class II

  FDA 510(k) K981382 Active Cleared 1 May 1998

• Pasv Dual Lumen Peripherally Inserted Central Catheter (Picc) Model Number Pic-Numerous

  Class II

  FDA 510(k) K981368 Active Cleared 1 May 1998

• 6 Inch Mini-Bone Extension Set with Luer Lock, NES01S, 6 Inch Min-Bone Extension Set with Luer Slip, NES02S, 6 Inch Stat

  Class II

  FDA 510(k) K980127 Active Cleared 11 Mar 1998

• Dual Lumen Midline Catheter

  Class II

  FDA 510(k) K010349 Active Cleared 28 Feb 2001

• Vaxcel Picc with Pasv Valve Technology

  Class II

  FDA 510(k) K021704 Active Cleared 6 Jun 2002

• Catheter Innovations Implantable Port

  Class II

  FDA 510(k) K993860 Active Cleared 3 Dec 1999

See all devices from Catheter Innovations, Inc. →