The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal Manometric Catheter.
| Device ID | K032138 |
| 510k Number | K032138 |
| Device Name: | MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER |
| Classification | Monitor, Esophageal Motility, And Tube |
| Applicant | MEDTRONIC VASCULAR 4000 LEXINGTON AVE., NORTH Shoreview, MN 55126 -2893 |
| Contact | Deborah Kidder |
| Correspondent | Deborah Kidder MEDTRONIC VASCULAR 4000 LEXINGTON AVE., NORTH Shoreview, MN 55126 -2893 |
| Product Code | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-11 |
| Decision Date | 2003-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05704736001328 | K032138 | 000 |
| 05704736001236 | K032138 | 000 |
| 05704736001243 | K032138 | 000 |
| 05704736001250 | K032138 | 000 |
| 05704736001267 | K032138 | 000 |
| 05704736001274 | K032138 | 000 |
| 05704736001281 | K032138 | 000 |
| 05704736001298 | K032138 | 000 |
| 05704736001304 | K032138 | 000 |
| 05704736001311 | K032138 | 000 |
| 05704736001229 | K032138 | 000 |