Atlas FDA

Vessel Dilator

FDA 510(k) clearance K163524 · decided 2017-06-29

Clearance details

K-number
K163524
Device name
Vessel Dilator
Applicant
Fetzer Medical GmbH & Co. KG
Decision
Substantially Equivalent
Date received
2016-12-15
Decision date
2017-06-29
Days to decision
196 days
Clearance type
Traditional
Product code
DWP
Device class
2
Regulation number
870.4475
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Tuttlingen, DE
Third-party review
No
Expedited review
No

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RecordFirmDate
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RDI CARDIAC INSULATION PAD (K960312)R D Intl.1996-04-19
LEMAITRE-BOOKWALTER VESSEL DEVICES (K912548)Vascutech, Inc.1991-09-18
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ROBICSEK PROBE/RETRACTOR (K910682)Bio-Vascular, Inc.1991-05-08
FLO-RESTER(R) VESSEL SIZER (K905159)Bio-Vascular, Inc.1991-02-07
FOGARTY VESSEL CALIBRATOR (K902143)Baxter Healthcare Corp1990-10-16
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Recalls involving this device

No recalls on record reference this clearance.