510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K093419Substantially Equivalent

Ivas 2-10Mm (10 Gauge) Balloon Catheter, Ivas 2-15 Mm(10 Gauge)0705-115-500, Ivas 3-10Mm(8 Gauge)balloon Catheter, Ivas

Stryker Corp., Kalamazoo MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093419 is the FDA 510(k) clearance record for IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS, a class II device, cleared for Stryker Instruments, Instruments Div. on under FDA product code NDN (Cement, Bone, Vertebroplasty). FDA records list 568 510(k) clearances for STRYKER CORP., from to . As of , FDA records show no recalls naming K093419.

Clearance record

Decision date
Received
(136 days to decision)
Product code
NDN Cement, Bone, Vertebroplasty
Regulation
21 CFR 888.3027
Device class
Class II
Review panel
Orthopedic
Applicant
Stryker Instruments, Instruments Div. 4100 E. Milham Ave., Kalamazoo MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NDN

Trailing 12 months
1 clearance under product code NDN in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NDN, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260