Datascope Collagen Products Division
Mahwah, NJ
Datascope Collagen Products Division appears in FDA device records in Mahwah, NJ. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 2
- Registered establishments
- 0
FDA records under these names
1 nameFDA records resolved to Datascope Collagen Products Division carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Datascope Interventional Products Divisionrecall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1315-04 | ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton. | The motor may fail to activate when the on/off switch is pressed. | Terminated | ||
| Z-0762-04 | VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920004), sterile (via gamma irradiation) device is sold in cardboard shelf cartons containing 5 ea. individual kits. The individual kits are packaged in a blister with Tyvek lid within a heat sealed foil pouch and fiberboard envelope. The device delivers collagen to the surface of the femoral artery following diagnostic or interventional catherization procedures using 5-8 Fr. procedural sheaths. The device is indicated for use in sealing the femoral arterial puncture site. | Kits are missing the temporary arteriotomy locator (TAL) from the blister package. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain