PeritX™ 1L Drainage Kit - Procedure Pack (50-

No FDA recalls found in the data synced 26 Oct 2026.

510(k) Number

K241946 ↗

FDA Product Code

PNG

Models / Variants

PeritX™ 1L Drainage Kit (90-1010)

PeritX™ 2L Drainage Kit (90-2010)

PeritX™ Peritoneal Catheter Kit (50-9000C)

PeritX™ Peritoneal Catheter and Starter Kit (50-9900C)

PeritX™ Peritoneal Catheter Mini Kit (50-9050A)

PleurX™ Low Profile Catheter Mini Kit (50-8050)

Valve Cap (50-7235A)

PeritX™ Valve Kit (50-7272)

Catheter Access Kit (50-7280A)

Lockable Drainage Line (50-7245A)

Lockable Drainage Line Kit (50-7265A)

PleurX™ Supplemental Insertion Kit (50-7262)

Procedure Pack (50-

Device Class

Class II

Regulation

21 CFR Part 876.5630

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Peripheral Vascular Sheath Tunneler Sterilization Cassette

  Class II

  FDA 510(k) K042062 Active Cleared 30 Sep 2004

• True Dilatation Balloon Valvuloplasty Catheter, 20mm X 4.5 Cm, 22mm X 4.5cm, 24 Mm X 4.5cm, 26mm X 4.5cm

  Class II

  FDA 510(k) K133569 Active Cleared 20 Dec 2013

• UltraCor™ Twirl™ Breast Tissue Marker

  Class II

  FDA 510(k) K243642 Active Cleared 24 Mar 2025

• Rotarex Atherectomy System Open recall

  Class II

  FDA 510(k) K242757 Active Cleared 30 Jan 2025

• Venaflo II Vascular Graft

  Class II

  FDA 510(k) K052282 Active Cleared 20 Sep 2005

• Fluency Plus Tracheobronchial Stent Graft

  Class II

  FDA 510(k) K050832 Active Cleared 7 Jul 2005

See all devices from Bard Peripheral Vascular, Inc. →