Monitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model HSJ-05065
FDA 510(k) K031153 · Arrow Intl., Inc.
510(k) numberK031153
Submission
- Device name
- Monitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model HSJ-05065
- Applicant
- Arrow Intl., Inc.
Reading, PA, US - Received
- April 11, 2003
- Decision date
- November 25, 2003
- 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 |
| K222242 | FloPatch FP120DPW · Traditional | Flosonics Medical | 12/09/2022SE |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special | Synovis Micro Companies Alliance, Inc. | 04/20/2022SE |
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| K071491 | Arrow International, Inc., Surgical DrapesKKX · Traditional | 10/10/2007SE |
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| K060309 | Autocat Intra-Aortic Balloon Pump SeriesDSP · Special | 04/06/2006SE |
| K042126 | PiccLJS · Special | 08/27/2004SESU |
| K041153 | Sharpsaway II Locking Disposable CupFMI · Traditional | 07/12/2004SE |
| K040801 | Intra-Aortic Balloon (Iab)DSP · Special | 05/06/2004SE |
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Questions and answers
When was Monitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model HSJ-05065 cleared by the FDA?
Monitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model HSJ-05065 (K031153) received a 510(k) decision of Substantially Equivalent on November 25, 2003, 228 days after the submission was received.
What is the product code of K031153?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.