The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Small Lumen Peritoneal Catheter.
Device ID | K073139 |
510k Number | K073139 |
Device Name: | SMALL LUMEN PERITONEAL CATHETER |
Classification | Shunt, Central Nervous System And Components |
Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
Contact | Jeffrey Henderson |
Correspondent | Jeffrey Henderson MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-07 |
Decision Date | 2008-01-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00613994173560 | K073139 | 000 |
00643169466807 | K073139 | 000 |
00763000028282 | K073139 | 000 |