Atlas FDA

CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350

FDA 510(k) clearance K023337 · decided 2002-11-18

Clearance details

K-number
K023337
Device name
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
2002-10-07
Decision date
2002-11-18
Days to decision
42 days
Clearance type
Traditional
Product code
KTI
Device class
2
Regulation number
874.4680
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
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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Vercise Deep Brain Stimulation (DBS) Systems (P150031/S096)Boston Scientific Corp2026-07-16
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S397)Boston Scientific Corp2026-07-10
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