Duns Number:103706391
Device Description: The Blowfish Transbronchial Micro-Infusion Catheter is a bronchoscope-guided device that c The Blowfish Transbronchial Micro-Infusion Catheter is a bronchoscope-guided device that contains a perpendicular stainless steel micro-needle port. This port is sheathed by and contained within a semi-rigid polymer actuator, which is connected to the flexible shaft. At the proximal end of the catheter shaft is the hub assembly.
Catalog Number
BH201M
Brand Name
Blowfish Micro-Infusion Catheter
Version/Model Number
MDL09-0616-145-34
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 04, 2019
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K131401
Product Code
EOQ
Product Code Name
Bronchoscope (Flexible Or Rigid)
Public Device Record Key
ad2b02d9-7247-4ff1-979c-66187c1a843b
Public Version Date
April 09, 2020
Public Version Number
5
DI Record Publish Date
January 20, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |