510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912798Substantially Equivalent

Amplantz and Bentson Guidewires

Meadox Medicals, Div. Boston Scientific Corp., Oakland NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912798 is the FDA 510(k) clearance record for AMPLANTZ AND BENTSON GUIDEWIRES, a class II device, cleared for Meadox Medicals, Div. Boston Scientific Corp. on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 53 510(k) clearances for Meadox Medicals, Div. Boston Scientific Corp., from to . As of , FDA records show no recalls naming K912798.

Clearance record

Decision date
Received
(90 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Meadox Medicals, Div. Boston Scientific Corp. 112 Bauer Dr., Oakland NJ
510(k) summary
Statement
Third party review
No

Clearances, product code DQX

Trailing 12 months
12 clearances under product code DQX in the twelve months to October 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20263
February 20260
March 20263
April 20260
May 20261
June 20260
July 20262
August 20260
September 20262
October 20260