Last synced on 24 June 2022 at 11:05 pm

Catheter Introducer

Page Type
Product Code
Definition
The catheter introducer is intended to provide a path for a catheter to be placed near nerves or into and around wound sites for the delivery local anesthesia.
Physical State
The needle is made from stainless steel material with a sharp beveled tip. The proximal end of the needle consist of a female luer made of polystyrene. The sheath tube consist of Soltex with a split -T hub. The sheath tube is scored the length of the tube.
Technical Method
The catheter introducer consist of a stainless steel needle with a sharp tip surrounded by a plastic peelable sheath. The needle with Sheath is inserted through the skin to the wound site or nerves for regional anesthesia. Once at the desired location the needle is removed and the catheter is inserted through the plastic sheath. With the catheter in place, the plastic sheath with a Split T handle is removed from the skin leaving the catheter in place.
Target Area
nerves
Review Panel
Anesthesiology
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code PNC is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Catheter Introducer

Page Type
Product Code
Definition
The catheter introducer is intended to provide a path for a catheter to be placed near nerves or into and around wound sites for the delivery local anesthesia.
Physical State
The needle is made from stainless steel material with a sharp beveled tip. The proximal end of the needle consist of a female luer made of polystyrene. The sheath tube consist of Soltex with a split -T hub. The sheath tube is scored the length of the tube.
Technical Method
The catheter introducer consist of a stainless steel needle with a sharp tip surrounded by a plastic peelable sheath. The needle with Sheath is inserted through the skin to the wound site or nerves for regional anesthesia. Once at the desired location the needle is removed and the catheter is inserted through the plastic sheath. With the catheter in place, the plastic sheath with a Split T handle is removed from the skin leaving the catheter in place.
Target Area
nerves
Review Panel
Anesthesiology
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code PNC is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.