CDRH New Update

CDRHNew

Date: January 31, 2017

The following new items were added to the CDRH web pages on January 30, 2017. Previous CDRH New Items can be found on the CDRHNew Page.

• Class I Medical Device Recall: Bard Peripheral Vascular Inc. Recalls Halo One Thin-Walled Guiding Sheath Due to Sheath Separation, Kinking, or Tip Damage
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150033 and DEN140024 added)