DeviceClearance

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT— 510(k) K173773

Substantially Equivalent

Bayer Medical Care, Inc.

FDA 510(k) clearance K173773 for MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT, Substantially Equivalent on 2018-08-17. Applicant: Bayer Medical Care, Inc.. Device class: 2.

Clearance details

Applicant
Bayer Medical Care, Inc.
Product code
Code DXT
Device class
Class 2
Regulation
21 CFR 870.1650
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianaola, PA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DXT

view all

More clearances from Bayer Medical Care, Inc.

view all

Adverse events under product code DXT

product code DXT
Death
39
Injury
242
Malfunction
463
Other
3
Total
747

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 →

Recalls naming K173773

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173773.

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