BRONCUS MEDICAL INC.

Address:125 Nicholson Ln,San Jose,CA,95134,US

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Bronchoscope (Flexible Or Rigid) (EOQ) (2) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

Clear

Archimedies Access Kit with Syringe - 00856571007234 Catalog Number : 10009-09

Device Description : A collection of sterile devices designed to access and perform a biopsy sample d A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy.

Device Class : 2

Duns Number: 078684808

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Empower RF Catheter - 00856571007241 Catalog Number : 10010

Device Description : The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver c The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver controlled radiofrequency (RF) energy to a target site within the upper airway or tracheobronchial tree when connected to a standard electrosurgical generator. The EMPOWER RF Catheter is inserted through the bronchoscope/extended working channel of 2.0 mm ID or greater to reach the target site.

Device Class : 2

Duns Number: 078684808

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Archimedes Access Key, 10-pack - 00856571007258 Catalog Number : 10009-2

Device Description : Archimedes Planning Software is software installed on a laptop computer used for Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue.

Device Class : 2

Duns Number: 078684808

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Archimedes Access Kit - 00856571007296 Catalog Number : 10009-9

Device Class : 2

Duns Number: 078684808

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Previous 1 2 Next