Acs Indeflator XX
FDA 510(k) K896849 · Advanced Cardiovascular Systems, Inc.
510(k) numberK896849
Submission
- Device name
- Acs Indeflator XX
- Applicant
- Advanced Cardiovascular Systems, Inc.
Temecula, CA, US - Received
- December 5, 1989
- Decision date
- February 28, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MAV – Syringe, Balloon Inflation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
Other 510(k)s with product code MAV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260035 | Digital Indeflator INFLANTEMAV · Traditional | UAB Telemedicina | 09/04/2026SE |
| K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and…MAV · Special | Medtronic Vascular | 04/13/2022SE |
| K162272 | Fluent inflation deviceMAV · Special | Vascular Solutions, Inc. | 10/20/2016SE |
| K153038 | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable…MAV · Special | Medtronic, Inc. | 04/13/2016SESK |
| K153672 | basixTOUCH40 Inflation SyringeMAV · Special | Merit Medical Systems, Inc. | 01/20/2016SESK |
| K152387 | Fluent Inflation DeviceMAV · Traditional | Vascular Solutions, Inc. | 12/18/2015SESK |
| K140943 | Mastro Plus Balloon In-Deflation DeviceMAV · Traditional | Beijing Demax Medical Technology Co.,Ltd | 03/05/2015SE |
| K143522 | Presto Inflation DeviceMAV · Traditional | C.R. Bard, Inc. | 01/12/2015SE |
| K133795 | Summed Inflation Device KitMAV · Traditional | Sunny Medical Device (Shenzhen) Co., Ltd. | 12/12/2014SE |
| K140745 | Encore 26 Advantage KitMAV · Special | Boston Scientific Corp | 04/17/2014SESK |
More from Boston Scientific Corp
| 510(k) | Device | Decision |
|---|---|---|
| K012534 | Hi-Torque Middle Support .012 Guide Wire with Hydrocoat Hydrophilic CoatingDQX · Traditional | 01/24/2002SE |
| K000550 | Otw Megalink SDS Biliary Stent SystemFGE · Special | 03/17/2000SESU |
| K994229 | Veripath Peripheral Guiding CatheterDQY · Special | 02/25/2000SE |
| K992169 | Acs Hi-Torque Cross-It 400XT Guide WireDQX · Traditional | 10/28/1999SE |
| K990867 | RX Herculink 14 Biliary Stent System, Model 1005126-18,1005128-18,1005130-18,1005132-18,1…FGE · Traditional | 09/02/1999SESU |
| K963702 | Acs Hi-Torque Iron Man Guide WireDQX · Traditional | 01/22/1997SE |
| K962495 | Indeflator Plus 30/PLUS 30 Priority PACK9WITH THE.096 OR.115 Rotating Hemostatic Valve)MAV · Traditional | 09/12/1996SE |
| K961471 | Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115…MAV · Traditional | 05/08/1996SESK |
| K955175 | Acs Anchor Exchange DeviceDQX · Traditional | 04/05/1996SE |
| K953987 | Acs Tourgide Guiding CatheterDQY · Traditional | 12/07/1995SE |
Questions and answers
When was Acs Indeflator XX cleared by the FDA?
Acs Indeflator XX (K896849) received a 510(k) decision of Substantially Equivalent on February 28, 1990, 85 days after the submission was received.
What is the product code of K896849?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.