PULSE*SPRAY INFUSION SYSTEM— 510(k) K961763
Substantially EquivalentAngiodynamics, Div. E-Z-Em, Inc.
FDA 510(k) clearance K961763 for PULSE*SPRAY INFUSION SYSTEM, Substantially Equivalent on 1996-07-17. Applicant: Angiodynamics, Div. E-Z-Em, Inc.. Device class: 2.
Clearance details
- Applicant
- Angiodynamics, Div. E-Z-Em, Inc.
- Product code
- Code QEY
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Queensburgy, NY, US
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More clearances from Angiodynamics, Div. E-Z-Em, Inc.
view allRecalls naming K961763
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 K961763.
Data sourced from openFDA. This site is unofficial and independent of the FDA.