510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Intervascular SAS

LA CIOTAT Bouches-du-Rhone, FR

Intervascular SAS appears in FDA device records in LA CIOTAT Bouches-du-Rhone, FR. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Intervascular SAS in 2011.

Clearances by year, as a table
510(k) clearance decisions for Intervascular SAS, by decision year
YearClearances
20111
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K103347CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESESDSYSubstantially Equivalent

Registered establishments

FDA registered establishments for Intervascular SAS, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
16402013002707083Intervascular SASZI Athelia 1, 270 voie Ariane, LA CIOTAT Bouches-du-Rhone 13600 FR2026

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-1439-2010InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.The external lid of Intervascular's prosthesis has a cut in it which may compromise package integrity and therefore sterility.Terminated
Z-1427-2010InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries.Packaging was mislabeled.Terminated

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