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Edwards eSheath+ Introducer set

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
Edwards eSheath+ Introducer set FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
Edwards eSheath+ Introducer set FDA UDI
Model / Reference
916ESP FDA UDI
Description
Edwards eSheath+ Introducer set FDA UDI

Identifiers

Catalog Number
916ESPA FDA UDI
Primary DI / UDI-DI
00690103215472 FDA UDI
510(k) Number
K200258 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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

Category: Vascular catheter introduction set, nonimplantable

A comprehensive medical device directory listing the Edwards eSheath+ Introducer set, including its features and regulatory compliance.

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Cleared under the same submission

K200258 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edwards Lifesciences LLC

Sources (1)

  • FDA UDI 229da540-2920-43bc-8b65-8e79036eb08d 38 fields · synced Jun 21, 2026