510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K203840Substantially Equivalent

BOSS 8F Balloon Guide Catheter

Marblehead Medical, Rochester Mn MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203840 is the FDA 510(k) clearance record for BOSS 8F Balloon Guide Catheter, a class II device, cleared for Marblehead Medical, LLC on under FDA product code QJP (Catheter, Percutaneous, Neurovasculature). FDA's definition for product code QJP reads: "To provide vascular access to the neurovasculature for interventional or diagnostic procedures". FDA records list 2 510(k) clearances for Marblehead Medical, LLC, from to . As of , FDA records show no recalls naming K203840.

Clearance record

Decision date
Received
(28 days to decision)
Product code
QJP Catheter, Percutaneous, Neurovasculature
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Marblehead Medical, LLC 753 Fox Chase Rd. SW, Rochester Mn MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QJP

Trailing 12 months
21 clearances under product code QJP in the twelve months to October 2026, April 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code QJP, trailing twelve months
MonthClearances
November 20250
December 20251
January 20263
February 20261
March 20260
April 20264
May 20262
June 20262
July 20263
August 20262
September 20262
October 20261