The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Softtouch(r) Guiding Catheter.
Device ID | K912199 |
510k Number | K912199 |
Device Name: | SOFTTOUCH(R) GUIDING CATHETER |
Classification | Catheter, Percutaneous |
Applicant | MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
Contact | David E Brown |
Correspondent | David E Brown MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-17 |
Decision Date | 1991-07-30 |