The following data is part of a premarket notification filed by Bostonscientific with the FDA for Boston Scientific Peripherally Inserted Central Catheter.
Device ID | K070002 |
510k Number | K070002 |
Device Name: | BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
Applicant | BOSTONSCIENTIFIC 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
Contact | Nicholas Condakes |
Correspondent | Nicholas Condakes BOSTONSCIENTIFIC 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
Product Code | LJS |
CFR Regulation Number | 880.5970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-03 |
Decision Date | 2007-08-17 |
Summary: | summary |