Atlas FDA

BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER

FDA 510(k) clearance K070002 · decided 2007-08-17

Clearance details

K-number
K070002
Device name
BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER
Applicant
Boston Scientific
Decision
Substantially Equivalent
Date received
2007-01-03
Decision date
2007-08-17
Days to decision
226 days
Clearance type
Abbreviated
Product code
LJS
Device class
2
Regulation number
880.5970
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Marlboro, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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ENDOTAK RELIANCE Leads (P910073/S182)Boston Scientific2025-10-24
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D010 INOGEN™ MINI ICD VR,D011 INOGEN™ MINI ICD VR,D012 INOGEN™ MINI ICD DR,D013 INOGEN™ MINI ICD DR,D020 DYNAGEN™ MINI I (P960040/S511)Boston Scientific2025-10-22
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