The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Dlp Single Stage Venous Cannula, Dlp Right Angle Single Stage Venous Cannula, Dlp Single Stage Venous Cannula With Right.
| Device ID | K120988 |
| 510k Number | K120988 |
| Device Name: | DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Jacqueline Hauge |
| Correspondent | Jacqueline Hauge MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-02 |
| Decision Date | 2012-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169697539 | K120988 | 000 |
| 00763000192631 | K120988 | 000 |
| 00763000192730 | K120988 | 000 |
| 00763000192747 | K120988 | 000 |
| 00763000192754 | K120988 | 000 |
| 00643169697140 | K120988 | 000 |
| 00643169697157 | K120988 | 000 |
| 00643169697164 | K120988 | 000 |
| 00643169697171 | K120988 | 000 |
| 00763000192624 | K120988 | 000 |
| 00763000192617 | K120988 | 000 |
| 00763000192532 | K120988 | 000 |
| 00763000192549 | K120988 | 000 |
| 00763000192556 | K120988 | 000 |
| 00763000192563 | K120988 | 000 |
| 00763000192570 | K120988 | 000 |
| 00763000192587 | K120988 | 000 |
| 00763000192594 | K120988 | 000 |
| 00763000192600 | K120988 | 000 |
| 00643169697188 | K120988 | 000 |
| 00643169697195 | K120988 | 000 |
| 00643169697300 | K120988 | 000 |
| 00643169697317 | K120988 | 000 |
| 00643169697324 | K120988 | 000 |
| 00643169697485 | K120988 | 000 |
| 00643169697492 | K120988 | 000 |
| 00643169697508 | K120988 | 000 |
| 00643169697515 | K120988 | 000 |
| 00643169697522 | K120988 | 000 |
| 00643169697294 | K120988 | 000 |
| 00643169697287 | K120988 | 000 |
| 00643169697201 | K120988 | 000 |
| 00643169697218 | K120988 | 000 |
| 00643169697225 | K120988 | 000 |
| 00643169697232 | K120988 | 000 |
| 00643169697249 | K120988 | 000 |
| 00643169697256 | K120988 | 000 |
| 00643169697263 | K120988 | 000 |
| 00643169697270 | K120988 | 000 |
| 00763000192525 | K120988 | 000 |