The following data is part of a premarket notification filed by Boston Scientific, Target with the FDA for In-time Retrieval Device.
Device ID | K014109 |
510k Number | K014109 |
Device Name: | IN-TIME RETRIEVAL DEVICE |
Classification | Device, Percutaneous Retrieval |
Applicant | BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
Contact | Seth A Schulman |
Correspondent | Seth A Schulman BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
Product Code | MMX |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-12-14 |
Decision Date | 2002-03-12 |
Summary: | summary |