The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Softouch Diagnostic Intravascular Catheter.
Device ID | K943739 |
510k Number | K943739 |
Device Name: | SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
Contact | Robert F Ingham |
Correspondent | Robert F Ingham MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-02 |
Decision Date | 1994-11-15 |