510(k) clearances

JetCan® Pro Safety Huber Needle

Pfm Medical, Inc. · General Hospital

K242763Substantially EquivalentTraditionalFPA
Open FDA's page for this record
Third party flag
N
City
Carlsbad
Advisory committee description
General Hospital
Address 1
1916 Palomar Oaks Way
Statement or summary
Summary
Product code
FPA
Zip code
92008
Applicant
Pfm Medical, Inc.
Decision date
2025-05-02
Decision code
SESE
Country code
US
Device name
JetCan® Pro Safety Huber Needle
Advisory committee
HO
Contact
Jessica Jho
K number
K242763
State
CA
Date received
2024-09-12
Review advisory committee
HO
Postal code
92008
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Set, Administration, Intravascular
Medical specialty description
General Hospital
Regulation number
880.5440
Device class
2
Registration number
3006174295, 3010131137, 3010291427, 3004122598, 1319639, 3015276780, 3008808123, 3008782867, 3009882464, 3014732157, 3015225571, 3014312726, 9615050, 1000587249, 3015060216, 1417485, 3035111606, 3005987567, 1644312, 1724474, 3011642792, 2320762, 3042871620, 9617592, 3010882065, 3010419931, 3044026004, 9615588, 8021083, 3014246639, 3007392007, 3004519921, 3003678543, 3015142721, 1419937, 3017567825, 3010293992, 8022210, 1019003, 2518902 +392 more
FEI number
3006174295, 3001436772, 3010131137, 3010291427, 3004122598, 3015276780, 3008808123, 3008782867, 3009882464, 1000160458, 3014732157, 3015225571, 3014312726, 1000587249, 3015060216, 1417485, 3035111606, 3005987567, 3000206435, 3011642792, 3003767881, 1000174591, 1000136478, 3042871620, 3010419931, 3044026004, 3001639729, 3014246639, 3007392007, 3003678543, 3015142721, 1419937, 3017567825, 3000215273, 3010293992, 1019003, 2518902, 3012116434, 3008252904, 3015859709 +392 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.