The following data is part of a premarket notification filed by Covidien Llc with the FDA for Arcpoint Pulmonary Needle - 18 Ga, Arcpoint Pulmonary Needle - 21 Ga.
| Device ID | K163537 |
| 510k Number | K163537 |
| Device Name: | Arcpoint Pulmonary Needle - 18 Ga, Arcpoint Pulmonary Needle - 21 Ga |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Covidien Llc 161 Cheshire Lane, Suite 100 Plymouth, MN 55441 |
| Contact | Leeanne Swiridow |
| Correspondent | Leeanne Swiridow Covidien Llc 161 Cheshire Lane, Suite 100 Plymouth, MN 55441 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-16 |
| Decision Date | 2017-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521723624 | K163537 | 000 |
| 20884521723617 | K163537 | 000 |
| 20884521809502 | K163537 | 000 |
| 20884521809496 | K163537 | 000 |