510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN090007Unknown

Bio-Seal Lung Biopsy Tract System

Angiotech, Vancouver, Bc, CA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN090007 is the FDA 510(k) clearance record for BIO-SEAL LUNG BIOPSY TRACT SYSTEM, a class II device, cleared for Angiotech on under FDA product code OMT (Absorbable Lung Biopsy Plug). FDA's definition for product code OMT reads: "A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic...". FDA records list 7 510(k) clearances for Angiotech, from to . As of , FDA records show no recalls naming DEN090007.

Clearance record

Decision date
Received
(1,342 days to decision)
Product code
OMT Absorbable Lung Biopsy Plug
Regulation
21 CFR 878.4755
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Angiotech 1618 Station St., Vancouver, Bc, CA
Third party review
No

Clearances, product code OMT

Trailing 12 months

FDA records hold no clearances under product code OMT in the trailing twelve months.

FDA records show no clearances under product code OMT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OMT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260