← Back to catalogue

Occlutech Pistol Pusher

FDA UDI

Class III (US FDA UDI)

by Occlutech Tibbi Urunler Sanayi Ve Ticaret Limited Sirketi

Identity

Trade Name
Occlutech Pistol Pusher FDA UDI
Generic Name
Cardiac defect occluder FDA UDI
Device Name
The Occlutech Pistol Pusher is a medical device compatible with the Occlutech Atrial Septal Defect Occluder (Occlutech ASD Occluder) and applications with special cardiac catheters in the human heart.The Occlutech Pistol Pusher is composed of proximal body and distal parts. The distal part consists of titanium alloy jaws and a stainless-steel container while the body part is polymer laminated stainless steel coil. The proximal parts of the Occlutech Pistol Pusher largely contains plastic components. The jaws and container mechanism grab and secure the ball connector of the compatible Occlutech ASD Occluder and allow retraction of the Occlutech ASD Occluder into the ODS III and advancement to the implant area. The proximal part has a trigger for releasing the compatible Occlutech ASD Occluder and a locking mechanism for locking the system to prevent unintentional release. The Occlutech Pistol Pusher is available in different sizes for compatibility with the Occlutech ASD Occluders. FDA UDI
Model / Reference
38PP210 FDA UDI
Description
The Occlutech Pistol Pusher is a medical device compatible with the Occlutech Atrial Septal Defect Occluder (Occlutech ASD Occluder) and applications with special cardiac catheters in the human heart.The Occlutech Pistol Pusher is composed of proximal body and distal parts. The distal part consists of titanium alloy jaws and a stainless-steel container while the body part is polymer laminated stainless steel coil. The proximal parts of the Occlutech Pistol Pusher largely contains plastic components. The jaws and container mechanism grab and secure the ball connector of the compatible Occlutech ASD Occluder and allow retraction of the Occlutech ASD Occluder into the ODS III and advancement to the implant area. The proximal part has a trigger for releasing the compatible Occlutech ASD Occluder and a locking mechanism for locking the system to prevent unintentional release. The Occlutech Pistol Pusher is available in different sizes for compatibility with the Occlutech ASD Occluders. FDA UDI

Identifiers

Catalog Number
38PP210 FDA UDI
Primary DI / UDI-DI
08683463400222 FDA UDI
PMA Number
P200032 FDA UDI
FDA Product Code
OZG FDA UDI
GMDN Term
Cardiac defect occluder FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
Outer Diameter — 3.23 Millimeter FDA UDI
Length — 120 Centimeter FDA UDI

Category: Cardiac defect occluder

Occlutech Pistol Pusher by Occlutech Tibbi Urunler Sanayi Ve Ticaret Limited Sirketi — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac defect occluder.

Cleared under the same submission

P200032 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
Occlutech Tibbi Urunler Sanayi Ve Ticaret Limited Sirketi

Sources (1)

  • FDA UDI 3e7ae94b-ed08-452e-9178-f7fe224890f7 38 fields · synced Jun 1, 2026