FDA Browser
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Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—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
K
24
3722
Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003)
2
Cleared 510(K)
DEN
09
0007
BIO-SEAL LUNG BIOPSY TRACT SYSTEM
2
Cleared 510(K)
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous
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 16 May 2025 at 11:05 pm
AN
/
subpart-e—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
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—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
K
24
3722
Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003)
DEN
09
0007
BIO-SEAL LUNG BIOPSY TRACT SYSTEM
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous
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
/
subpart-e—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