Last synced on 21 February 2025 at 11:05 pm

Laser-Powered Inferior Vena Cava Filter Retrieval Catheter

Page Type
Product Code
Definition
A laser-powered inferior vena cava (IVC) filter retrieval catheter is a percutaneous catheter that uses a laser to ablate tissue and is intended to facilitate in the detachment and removal of indwelling IVC filters.
Physical State
Laser catheter
Technical Method
Removal of indwelling IVF filter through ablation of tissue.
Target Area
Inferior Vena Cava
Regulation Medical Specialty
Cardiovascular
Review Panel
Cardiovascular
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.5125
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QRJ is linked to regulation 21CFR870.5125, which does not seem to exist yet. It may be pending at the moment.

Laser-Powered Inferior Vena Cava Filter Retrieval Catheter

Page Type
Product Code
Definition
A laser-powered inferior vena cava (IVC) filter retrieval catheter is a percutaneous catheter that uses a laser to ablate tissue and is intended to facilitate in the detachment and removal of indwelling IVC filters.
Physical State
Laser catheter
Technical Method
Removal of indwelling IVF filter through ablation of tissue.
Target Area
Inferior Vena Cava
Regulation Medical Specialty
Cardiovascular
Review Panel
Cardiovascular
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.5125
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QRJ is linked to regulation 21CFR870.5125, which does not seem to exist yet. It may be pending at the moment.