E-Z-EM PULSED INFUSION SYSTEM— 510(k) K905447
Substantially EquivalentE-Z-Em, Inc.
FDA 510(k) clearance K905447 for E-Z-EM PULSED INFUSION SYSTEM, Substantially Equivalent on 1991-04-01. Applicant: E-Z-Em, Inc.. Device class: 2.
Clearance details
- Applicant
- E-Z-Em, Inc.
- Product code
- Code KRA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Worcester, MA, US
Recent devices under product code KRA
view allMore clearances from E-Z-Em, Inc.
view allAdverse events under product code KRA
product code KRA- Death
- 234
- Injury
- 1,029
- Malfunction
- 3,012
- Other
- 2
- Total
- 4,277
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 K905447
K-number listed on FDA's recall record- Z-2260-2014 — Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
- Z-2261-2014 — Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
- Z-2262-2014 — Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K905447.
Data sourced from openFDA. This site is unofficial and independent of the FDA.