MODIFIED THORACENTESIS CATHETER— 510(k) K811437

Substantially Equivalent

Blair Medical Products

FDA 510(k) clearance K811437 for MODIFIED THORACENTESIS CATHETER, Substantially Equivalent on 1981-08-13. Applicant: Blair Medical Products.

Clearance details

Applicant
Blair Medical Products
Product code
Code KDQ
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KDQ

product code KDQ
Death
8
Malfunction
637
Total
645

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.