← Back to catalogue

Spex35

FDA UDI

Class II (US FDA UDI)

by Reflow Medical, Inc.

Identity

Trade Name
SPEX35 FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
Spex Shapeable Support Catheter, 35 X 50cm, US FDA UDI
Model / Reference
SPN35050US FDA UDI
Description
Spex Shapeable Support Catheter, 35 X 50cm, US FDA UDI

Identifiers

Primary DI / UDI-DI
00850025525060 FDA UDI
510(k) Number
K173662 FDA UDI
FDA Product Code
DQY FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 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

No

FDA UDI

Dimensions & Sizes

Size
Catheter Working Length — 50 Centimeter FDA UDI
Guidewire Diameter — .035 Inch FDA UDI

Category: Vascular guide-catheter, single-use

Spex35 by Reflow Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular guide-catheter, single-use.

Cleared under the same submission

K173662 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Reflow Medical, Inc.

Sources (1)

  • FDA UDI 553a3fe2-a625-4ada-a3df-207686b81548 36 fields · synced Jun 8, 2026