The following data is part of a premarket notification filed by Aqueduct Critical Care, Inc. with the FDA for Smart External Drain (sed) System.
| Device ID | K161605 |
| 510k Number | K161605 |
| Device Name: | Smart External Drain (SED) System |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | AQUEDUCT CRITICAL CARE, INC. 11822 NORTH CREEK PARKWAY NORTH SUITE 110 Bothell, WA 98011 |
| Contact | Thomas Clement |
| Correspondent | Thomas Clement AQUEDUCT CRITICAL CARE, INC. 11822 NORTH CREEK PARKWAY NORTH SUITE 110 Bothell, WA 98011 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-10 |
| Decision Date | 2016-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| ACCKIT100 | K161605 | 000 |
| ACCHLD100 | K161605 | 000 |
| ACCCON100 | K161605 | 000 |
| ACCCART100 | K161605 | 000 |
| ACCBAG100 | K161605 | 000 |