The following data is part of a premarket notification filed by Covidien with the FDA for Tal Pallindrome (tm) Symmetric Tip Dual Lumen Catheter, Mahurkar (r) Maxid (tm) Dual Lumen Catheter, Palindrome (tm)....
| Device ID | K111372 |
| 510k Number | K111372 |
| Device Name: | TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Wing Ng |
| Correspondent | Wing Ng COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-16 |
| Decision Date | 2011-08-04 |
| Summary: | summary |