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Optima Coil System

FDA UDI

Class II (US FDA UDI)

by Balt Usa Llc

Identity

Trade Name
Optima Coil System FDA UDI
Generic Name
Non-neurovascular embolization coil FDA UDI
Device Name
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller. FDA UDI
Model / Reference
PRES0713CPK10 FDA UDI
Description
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller. FDA UDI

Identifiers

Primary DI / UDI-DI
00818053023729 FDA UDI
510(k) Number
K172390 FDA UDI
FDA Product Code
KRD FDA UDI
GMDN Term
Non-neurovascular embolization coil FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Non-neurovascular embolization coil

Optima Coil System by Balt Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-neurovascular embolization coil.

Cleared under the same submission

K172390 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Balt Usa Llc

Sources (1)

  • FDA UDI 7c894d7b-73af-4acf-89b0-d0ffa63e13d5 37 fields · synced May 30, 2026