FDA Registration Active 🇺🇸 United States

SKYDANCE VASCULAR, INC.

Reg #: 3022054170 · FEI: 3022054170 · Expires 2026
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1

Registration Details

Registration Name
SKYDANCE VASCULAR, INC.
Registration Number
3022054170
FEI Number
3022054170
Status
Active
Expiry Year
2026
Initial Importer
No
Address
3058 Millcreek Rd.
City
Pleasant Grove
State
UT
ZIP
84062
Country
US

Regulatory Submissions

510(k) Number
K223018

Owner / Operator

Firm Name
SkyDance Vascular, Inc.
Operator Number
10087996
Address
3058 Millcreek Rd.
City
Pleasant Grove
State
UT
Postal Code
84062
Country
US
Correspondent
Scott J Pease

Products

Device Name Product Code
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ

Proprietary Names

OSPREY PERIPHERAL IV Catheter System OSPREY Closed IV Catheter System (OspreyV2) OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility