Vascular Assist
FDA 510(k) K002186 · Huntleigh Healthcare, Inc.
510(k) numberK002186
Submission
- Device name
- Vascular Assist
- Applicant
- Huntleigh Healthcare, Inc.
Eatontown, NJ, US - Received
- July 20, 2000
- Decision date
- May 2, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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| K223843 | FloPatch FP120DPW · Traditional | Flosonics Medical | 05/03/2023SE |
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| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special | Synovis Micro Companies Alliance, Inc. | 04/20/2022SE |
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| K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHGM · Traditional | 06/24/2020SE |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesDPW · Abbreviated | 09/06/2019SE |
| K152228 | Hydroven 12, Hydroven 12 GarmentsJOW · Traditional | 04/04/2016SE |
| K132650 | Sonicaid Freedom Wireless Fetal Monitoring SystemHGM · Traditional | 02/07/2014SE |
| K121108 | Dopplex AbilityJOM · Traditional | 01/03/2013SE |
| K090285 | Sonicaid FM820 and FM830 EncoreHGM · Traditional | 07/15/2009SE |
Questions and answers
When was Vascular Assist cleared by the FDA?
Vascular Assist (K002186) received a 510(k) decision of Substantially Equivalent on May 2, 2001, 286 days after the submission was received.
What is the product code of K002186?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.