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SavvyWire

FDA UDI

Class II (US FDA UDI)

by Opsens

Identity

Trade Name
SavvyWire FDA UDI
Generic Name
Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name
Pre-Shaped Pressure Guidewire FDA UDI
Model / Reference
X-Small FDA UDI
Description
Pre-Shaped Pressure Guidewire FDA UDI

Identifiers

Catalog Number
F3001 FDA UDI
Primary DI / UDI-DI
07540184030019 FDA UDI
510(k) Number
K213854 FDA UDI
FDA Product Code
DQX FDA UDI
DXO FDA UDI
LDF FDA UDI
GMDN Term
Cardiac/peripheral vascular guidewire, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1330 FDA UDI
870.2870 FDA UDI
870.3680 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

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cardiac/peripheral vascular guidewire, single-use

SavvyWire by Opsens — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac/peripheral vascular guidewire, single-use.

Cleared under the same submission

K213854 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Opsens

Sources (1)

  • FDA UDI 042f331e-ed0d-4ace-8d29-595020daaf4e 38 fields · synced Jun 8, 2026