DeviceClearance

K063071

Substantially Equivalent

DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B

Applicant
Kyphon, Inc.
Product code
BSP
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Sunnyvale, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code BSP

product code BSP
Death
2
Total
2

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.