The following data is part of a premarket notification filed by Cair Lgl with the FDA for Cair Drive, Neutraclear.
| Device ID | K133073 |
| 510k Number | K133073 |
| Device Name: | CAIR DRIVE, NEUTRACLEAR |
| Classification | Set, Administration, Intravascular |
| Applicant | CAIR LGL 420 LEXINGTON AVE. STE. 2400 New York, NY 10170 |
| Contact | Irving Wiesen |
| Correspondent | Irving Wiesen CAIR LGL 420 LEXINGTON AVE. STE. 2400 New York, NY 10170 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-03-20 |
| Summary: | summary |