Atlas FDA

MULTI-SNARE SET

FDA 510(k) clearance K011783 · decided 2002-01-24

Clearance details

K-number
K011783
Device name
MULTI-SNARE SET
Applicant
Pfm Produkte Fur Die Medizin AG
Decision
Substantially Equivalent
Date received
2001-06-07
Decision date
2002-01-24
Days to decision
231 days
Clearance type
Traditional
Product code
DXE
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Trabuco Canyon, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 recall (Z-2526-2026)PFM MEDICAL INC.2026-06-23