Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054
FDA 510(k) K100769 · Penumbra, Inc.
Submission
- Device name
- Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054
- Applicant
- Penumbra, Inc.
Alameda, CA, US - Received
- March 18, 2010
- Decision date
- May 21, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRY – Catheter, Thrombus Retriever
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
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Questions and answers
When was Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054 cleared by the FDA?
Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054 (K100769) received a 510(k) decision of Substantially Equivalent on May 21, 2010, 64 days after the submission was received.
What is the product code of K100769?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.