Peripherally Inserted Central Venous Catheter

• • Terminated Z-1275-2015 FDA Class II ·initiated 8 Aug 2014

  Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.

510(k) Number

K871080 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the peripherally inserted central venous catheter designed for?

  This device is designed for venous access in patients requiring prolonged intravenous therapy. It is inserted through a peripheral vein and advanced into a central vein, allowing reliable and sustained administration of fluids, medications, and nutritional support in clinical settings where extended treatment is necessary.

• How is the peripherally inserted central venous catheter supplied and intended for use?

  The catheter is supplied sterile and is intended for single-use only. This ensures patient safety by preventing contamination and cross-infection, which is critical for medical devices used in direct vascular access.

• Is this device MRI-safe?

  The provided data does not indicate that this peripherally inserted central venous catheter is MRI-safe. Patients requiring MRI scans while using this device should consult their healthcare provider for guidance, as metal components or materials could pose risks in magnetic fields.

• What regulatory pathway does this device follow?

  This peripherally inserted central venous catheter is regulated under the FDA’s 510(k) clearance process, specifically under clearance number K871080. It was determined to be substantially equivalent to a legally marketed predicate device and falls under the Cardiovascular advisory committee’s jurisdiction.

• How should this device be stored and handled?

  The device should be stored and handled according to standard sterile medical device protocols to maintain its integrity and sterility. This includes keeping it in a sealed, sterile packaging until use and following manufacturer guidelines for preparation and insertion to minimize contamination risks.