Atlas FDA

CENTRAL VENOUS CATHETER

FDA 510(k) clearance K003839 · decided 2001-08-01

Clearance details

K-number
K003839
Device name
CENTRAL VENOUS CATHETER
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
2000-12-12
Decision date
2001-08-01
Days to decision
232 days
Clearance type
Traditional
Product code
LJS
Device class
2
Regulation number
880.5970
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Natick,, 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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ALTRUA™ 2 (Models S701, S702, S722) ESSENTIO™ (Models L100, L101, L121) PROPONENT™ (Models L200, L201, L221) ACCOLADE™ ( (N970003/S304)Boston Scientific Corp2025-12-19
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WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S082)Boston Scientific Corp2025-12-18
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S090)Boston Scientific Corp2025-12-17
ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321) (N970003/S305)Boston Scientific Corp2025-12-17
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S390)Boston Scientific Corp2025-12-17
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S079)Boston Scientific Corp2025-12-15
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S078)Boston Scientific Corp2025-12-15