Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam Embolization Particles
FDA 510(k) K053548 · Protein Polymer Technologies, Inc.
510(k) numberK053548
Submission
- Device name
- Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam Embolization Particles
- Applicant
- Protein Polymer Technologies, Inc.
San Diego, CA, US - Received
- December 20, 2005
- Decision date
- January 30, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K061790 | Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesKRD · Traditional | 09/19/2006SE |
Questions and answers
When was Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam Embolization Particles cleared by the FDA?
Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam Embolization Particles (K053548) received a 510(k) decision of Substantially Equivalent on January 30, 2006, 41 days after the submission was received.
What is the product code of K053548?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.