We're working on improving this tool, so please
email us
suggestions.
Sign up
for email updates to learn about new features.
✕
FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular Diagnostic Devices
CFR Sub-Part
Cardiovascular Monitoring Devices
CFR Sub-Part
Cardiovascular Therapeutic Devices
CFR Sub-Part
Diagnostic Devices
CFR Sub-Part
Miscellaneous
CFR Sub-Part
Monitoring Devices
CFR Sub-Part
Neurological Therapeutic Devices
CFR Sub-Part
Physical Medicine Therapeutic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
LLO
Laser, Neodymium:Yag, Pulmonary Surgery
2
Product Code
NQV
Catheter, Suction, Tracheobronchial, Reprocessed
1
Product Code
QEC
Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
2
Product Code
OMT
Absorbable Lung Biopsy Plug
2
Product Code
DEN
09
0007
BIO-SEAL LUNG BIOPSY TRACT SYSTEM
2
Cleared 510(K)
Therapeutic Devices
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 24 March 2023 at 11:04 pm
AN
/
surgical-devices
/
OMT
/
DEN090007
View Source
BIO-SEAL LUNG BIOPSY TRACT SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN090007
510(k) Type
Post-NSE
Applicant
ANGIOTECH
Country
Canada
FDA Decision
Deleted
Decision Date
12/19/2012
Days to Decision
1342 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular Diagnostic Devices
Cardiovascular Monitoring Devices
Cardiovascular Therapeutic Devices
Diagnostic Devices
Miscellaneous
Monitoring Devices
Neurological Therapeutic Devices
Physical Medicine Therapeutic Devices
Prosthetic Devices
Surgical Devices
LLO
Laser, Neodymium:Yag, Pulmonary Surgery
NQV
Catheter, Suction, Tracheobronchial, Reprocessed
QEC
Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
OMT
Absorbable Lung Biopsy Plug
DEN
09
0007
BIO-SEAL LUNG BIOPSY TRACT SYSTEM
Therapeutic Devices
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
surgical-devices
/
OMT
/
DEN090007
View Source
BIO-SEAL LUNG BIOPSY TRACT SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN090007
510(k) Type
Post-NSE
Applicant
ANGIOTECH
Country
Canada
FDA Decision
Deleted
Decision Date
12/19/2012
Days to Decision
1342 days