Atlas FDA

ASEPT PLEURAL DRAINAGE SYSTEM

FDA 510(k) clearance K093307 · decided 2009-11-06

Clearance details

K-number
K093307
Device name
ASEPT PLEURAL DRAINAGE SYSTEM
Applicant
Pfm Medical, Inc.
Decision
Substantially Equivalent
Date received
2009-10-22
Decision date
2009-11-06
Days to decision
15 days
Clearance type
Traditional
Product code
DWM
Device class
2
Regulation number
870.5050
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Oceanside, CA, US
Third-party review
Yes
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE (K121849)Care Fusion2012-10-18
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Recalls involving this device

RecordFirmDate
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Pro recall (Z-0561-2015)Pfm Medical Inc2014-12-12
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is recall (Z-0562-2015)Pfm Medical Inc2014-12-12

PMA approvals by this applicant

RecordFirmDate
NIT-OCCLUD PDA (P120009/S004)Pfm Medical, Inc.2024-10-17
PMA NIT-OCCLUD PDA (P120009/S003)Pfm Medical, Inc.2016-12-16
NIT-OCCLUD SYSTEM (P120009/S002)Pfm Medical, Inc.2015-01-21
NIT-OCCLUD PDA (P120009/S001)Pfm Medical, Inc.2014-08-01
NIT-OCCLUD PDA (P120009)Pfm Medical, Inc.2013-08-16