Tag: 510K
INFINITY Angioplasty Balloon Catheter receives 510(k) clearance
The Infinity Angioplasty Balloon Company has announced that its balloon platform—the INFINITY Angioplasty Balloon Catheter—has been cleared by the US Food and Drug Administration...
FDA issues guidance on PTA balloon and specialty catheter 510(k) submissions
The US Food and Drug Administration (FDA) has released draft guidance detailing the information device-makers should include in 510(k) submissions of catheter-based devices intended...
