Medline Catheterization and Angiography Kits Regulatory Clearance Rescinded
Medline Industries has had its 510(k) regulatory clearances rescinded for certain Control Syringes, Guidewires, and High-Pressure Tubing used in a large number of catheterization and angiography kits. The kits are distributed nationwide.
- Product
- Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number: DYNJT57
- Category
- Medical Device
- Distribution
- Distributed nationwide