Medrad Counterpoise System
FDA 510(k) K944983 · Medrad, Inc.
510(k) numberK944983
Submission
- Device name
- Medrad Counterpoise System
- Applicant
- Medrad, Inc.
Pittsburgh, PA, US - Received
- October 11, 1994
- Decision date
- November 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K113133 | Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion…DXT · Special | 12/15/2011SE |
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| K111182 | Angiojet Solent Omni Thrombectomy SetQEZ · Special | 05/24/2011SE |
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Questions and answers
When was Medrad Counterpoise System cleared by the FDA?
Medrad Counterpoise System (K944983) received a 510(k) decision of Substantially Equivalent on November 29, 1994, 49 days after the submission was received.
What is the product code of K944983?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.