Atlas FDA

VASCULAR PROBE, VASCULAR PROBE ES

FDA 510(k) clearance K130896 · decided 2013-04-24

Clearance details

K-number
K130896
Device name
VASCULAR PROBE, VASCULAR PROBE ES
Applicant
Synovis Life Technologies, Inc.
Decision
Substantially Equivalent
Date received
2013-04-01
Decision date
2013-04-24
Days to decision
23 days
Clearance type
Traditional
Product code
DWP
Device class
2
Regulation number
870.4475
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
St. Paul, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS1 recall (Z-1524-2024)Baxter Healthcare Corporation2024-04-12
Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, recall (Z-0659-2024)Baxter Healthcare Corporation2024-01-05