510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Xvivo Perfusion, Inc.

Molndal Vastra Gotaland, SE

XVIVO PERFUSION, INC. appears in FDA device records in Molndal Vastra Gotaland, SE. FDA records list 4 510(k) clearances between and , 13 PMA records and 3 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
4
PMA records
13
Recall records
1
Registered establishments
3

510(k) clearance history

FDA records hold 4 510(k) clearances for Xvivo Perfusion, Inc. between 2010 and 2026. The busiest year on record is 2010, with 1. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Xvivo Perfusion, Inc., by decision year
YearClearances
20101
20181
20221
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261644Perfadex PlusKDNSubstantially Equivalent
K211333KIDNEY ASSIST-transportKDNSubstantially Equivalent
K170826Perfadex PlusKDNSubstantially Equivalent
K091989PERFADEX AND PERFADEX WITH THAMKDNSubstantially Equivalent

Registered establishments

FDA registered establishments for Xvivo Perfusion, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30077106033007710603XVIVO PERFUSION ABEntreprenorsstraket 10, Molndal Vastra Gotaland 43153 SE2026
30097369253009736925XVIVO PERFUSION, INC.16080 Table Mountain Pkwy Ste 500, Golden, CO 80403 US2026
30289078623028907862XVIVO PERFUSION, INC.3250 Quentin Street, Suite #134, Aurora, CO 80011 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1212-2022XVIVO Organ Chamber REF 19020The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain