The following data is part of a premarket notification filed by Percuvision with the FDA for Directvision Catheter, Uncoated.
| Device ID | K110214 |
| 510k Number | K110214 |
| Device Name: | DIRECTVISION CATHETER, UNCOATED |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | PERCUVISION 200 HOMER AVE, 2ND FLOOR Ashland, MA 01721 |
| Contact | Fides Maldonado |
| Correspondent | Fides Maldonado PERCUVISION 200 HOMER AVE, 2ND FLOOR Ashland, MA 01721 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-25 |
| Decision Date | 2011-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10855308006011 | K110214 | 000 |
| 10855308006004 | K110214 | 000 |