The following data is part of a premarket notification filed by Hemedex Incorporated with the FDA for Qflow 500 Titanium Bolt, Quad Lumen Bolt Kit.
| Device ID | K141869 |
| 510k Number | K141869 |
| Device Name: | QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | HEMEDEX INCORPORATED 222 3rd St Suite 0123 Cambridge, MA 02142 |
| Contact | Dean Honkonen |
| Correspondent | Dean Honkonen HEMEDEX INCORPORATED 222 3rd St Suite 0123 Cambridge, MA 02142 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-11 |
| Decision Date | 2014-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B238H000036850 | K141869 | 000 |
| B238H000036020 | K141869 | 000 |
| B238H000036110 | K141869 | 000 |
| B238H000036120 | K141869 | 000 |
| B238H000036310 | K141869 | 000 |
| B238H000036320 | K141869 | 000 |
| B238H000036420 | K141869 | 000 |
| B238H000036440 | K141869 | 000 |
| B238H000036810 | K141869 | 000 |
| B238H000036830 | K141869 | 000 |
| B238H000036840 | K141869 | 000 |
| B238H000036010 | K141869 | 000 |