Condor Analog Inflation Syringe
FDA 510(k) K904508 · Professional Medical Services
510(k) numberK904508
Submission
- Device name
- Condor Analog Inflation Syringe
- Applicant
- Professional Medical Services
North Salt Lake, UT, US - Received
- October 4, 1990
- Decision date
- April 2, 1991
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K913094 | Disposable Slide Valve ManifoldDQO · Traditional | 01/27/1992SE |
| K910378 | Pressure Monitoring Extension LineDQO · Traditional | 04/22/1991SE |
| K904954 | Condor Digital Inflation SyringeMAV · Traditional | 01/16/1991SE |
| K902606 | Radiopaque RulerKPR · Traditional | 09/27/1990SE |
| K884577 | Procedure Ready TraysFOZ · Traditional | 08/01/1989SESD |
| K890471 | PMS Angio DrapeKKX · Traditional | 02/27/1989SE |
| K884497 | Control SyringeFMF · Traditional | 12/12/1988SE |
| K872448 | Blood Containment PackLRO · Traditional | 11/17/1987SE |
| K864555 | 3 Ring AttachmentFMF · Traditional | 12/01/1986SE |
| K854941 | PMS Percutaneous Puncture NeedleDYB · Traditional | 04/16/1986SE |
Questions and answers
When was Condor Analog Inflation Syringe cleared by the FDA?
Condor Analog Inflation Syringe (K904508) received a 510(k) decision of Substantially Equivalent on April 2, 1991, 180 days after the submission was received.
What is the product code of K904508?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.