Identity
- Trade Name
- PulseSpray FDA UDI
- Generic Name
- Peripheral vascular intervention infusion catheter FDA UDI
- Device Name
- PulseSpray Infusion System FDA UDI
- Model / Reference
- H787125004520 FDA UDI
- Description
- PulseSpray Infusion System FDA UDI
Identifiers
- Catalog Number
- 12500452 FDA UDI
- Primary DI / UDI-DI
- 15051684013581 FDA UDI
- 510(k) Number
- K163356 FDA UDI
- FDA Product Code
- KRA FDA UDI
- GMDN Term
- Peripheral vascular intervention infusion catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 4 French FDA UDILength — 90 Centimeter FDA UDI
Category: Peripheral vascular intervention infusion catheter
PulseSpray by Angiodynamics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K163356 also covers:
- PulseSpray — ANGIODYNAMICS, INC
- PulseSpray — ANGIODYNAMICS, INC
- PulseSpray — ANGIODYNAMICS, INC
- PulseSpray — ANGIODYNAMICS, INC
- PulseSpray — ANGIODYNAMICS, INC
- PulseSpray — ANGIODYNAMICS, INC
- PulseSpray — ANGIODYNAMICS, INC
- PulseSpray — ANGIODYNAMICS, INC
- PulseSpray — ANGIODYNAMICS, INC
- PulseSpray — ANGIODYNAMICS, INC
- PulseSpray — ANGIODYNAMICS, INC
- PulseSpray — ANGIODYNAMICS, INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Angiodynamics, Inc
Sources (1)
- FDA UDI c6771dca-e886-4b6f-8cb7-cb663a972d10 38 fields · synced Jun 20, 2026