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 |