POD SYSTEM
Device, Neurovascular Embolization
PENUMBRA, INC.
The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Pod System.
Pre-market Notification Details
| Device ID | K141134 |
| 510k Number | K141134 |
| Device Name: | POD SYSTEM |
| Classification | Device, Neurovascular Embolization |
| Applicant | PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda, CA 94502 |
| Contact | Charles Denault |
| Correspondent | Charles Denault PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda, CA 94502 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-01 |
| Decision Date | 2014-07-03 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M424RBYPODJ450 | K141134 | 000 |
Trademark Results [POD SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POD SYSTEM 78559630 not registered Dead/Abandoned |
CURTIS INDUSTRIES, LLC 2005-02-03 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.