510(k) K011811 ยท DXT Injector And Syringe, Angiographic
MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Aug 22, 2001 |
| Received | Jun 11, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011811
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2024 | Merit Medical Systems, Inc. Monarch Inflation Device 30 atm/bar REF IN2130
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters Open, Classified |
DXT | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch s Open, Classified |
DXT | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syri Open, Classified |
DXT | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syring Open, Classified |
DXT | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 Open, Classified |
DXT | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. Melrose Wakefield Hospital REF K05T-2159
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to Open, Classified |
DXT | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B Open, Classified |
DXT | None listed |
| Sep 9, 2011 | Medtronic Spine LLC (formerly Kyphon Inc.) Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC (formerly known as K Terminated |
HRX | None listed |
| Jul 20, 2004 | Kyphon Inc KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A.
Kyphon Catalog Number: A08A. The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation S Terminated |
DXT | None listed |
| Nov 19, 2003 | Merit Medical Systems, Inc Monarch Inflation Device and Fluid Dispensing Syringe - Latex Free MERIT MEDICAL. Sterile if package is unopened or undamaged. Part # IN2125/B . Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.