The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Pod Packing Coil.
| Device ID | K170852 |
| 510k Number | K170852 |
| Device Name: | POD Packing Coil |
| Classification | Device, Neurovascular Embolization |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Aditi Kolla |
| Correspondent | Aditi Kolla Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-22 |
| Decision Date | 2017-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548017679 | K170852 | 000 |
| 00814548017761 | K170852 | 000 |
| 00814548017754 | K170852 | 000 |
| 00814548017747 | K170852 | 000 |
| 00814548017730 | K170852 | 000 |
| 00814548017723 | K170852 | 000 |
| 00814548017716 | K170852 | 000 |
| 00814548017709 | K170852 | 000 |
| 00814548017693 | K170852 | 000 |
| 00814548017778 | K170852 | 000 |
| 00814548017785 | K170852 | 000 |
| 00814548017662 | K170852 | 000 |
| 00814548017655 | K170852 | 000 |
| 00814548017648 | K170852 | 000 |
| 00814548017631 | K170852 | 000 |
| 00814548017822 | K170852 | 000 |
| 00814548017815 | K170852 | 000 |
| 00814548017808 | K170852 | 000 |
| 00814548017792 | K170852 | 000 |
| 00814548017686 | K170852 | 000 |