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ClampEase Vascular Compression Device

FDA UDI

Class II (US FDA UDI)

by Semler Technologies, Inc.

Identity

Trade Name
ClampEase Vascular Compression Device FDA UDI
Generic Name
Femoral artery compression system, manual, reusable FDA UDI
Device Name
The ClampEase mechanical compression device provides a hands-free approach for hemostasis following femoral artery catheterization procedures. The ClampEase Stystem is comprised of a durable ClampEase Stand and a sterile, disposable ball or taper style Disc. The Model C-750 ClampEase System is compatible with those styles of Discs that are designed for Taper Tip Attachment. FDA UDI
Model / Reference
C-750 FDA UDI
Description
The ClampEase mechanical compression device provides a hands-free approach for hemostasis following femoral artery catheterization procedures. The ClampEase Stystem is comprised of a durable ClampEase Stand and a sterile, disposable ball or taper style Disc. The Model C-750 ClampEase System is compatible with those styles of Discs that are designed for Taper Tip Attachment. FDA UDI

Identifiers

Catalog Number
160-2010-05 FDA UDI
Primary DI / UDI-DI
10815614020637 FDA UDI
510(k) Number
K964662 FDA UDI
FDA Product Code
DXC FDA UDI
GMDN Term
Femoral artery compression system, manual, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Femoral artery compression system, manual, reusable

ClampEase Vascular Compression Device by Semler Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femoral artery compression system, manual, reusable.

Cleared under the same submission

K964662 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Semler Technologies, Inc.

Sources (1)

  • FDA UDI 8f6b3e13-ba90-415b-9450-1c933c77b856 35 fields · synced May 31, 2026