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Mitraclip

FDA UDI

Class II (US FDA UDI)

by Abbott Vascular

Identity

Trade Name
MITRACLIP FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
Steerable Guide Catheter FDA UDI
Model / Reference
SGC0701 FDA UDI
Description
Steerable Guide Catheter FDA UDI

Identifiers

Catalog Number
SGC0701 FDA UDI
Primary DI / UDI-DI
08717648231025 FDA UDI
510(k) Number
K190167 FDA UDI
FDA Product Code
DRA FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1280 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

Category: Vascular guide-catheter, single-use

Mitraclip by Abbott Vascular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Vascular

Sources (1)

  • FDA UDI 1a16471f-6d50-49e1-8431-98cf99991d55 37 fields · synced Jun 8, 2026