Flowcardia, Inc.
Sunnyvale, CA, US
Flowcardia, Inc. appears in FDA device records in Sunnyvale, CA. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Flowcardia, Inc. between 2005 and 2010. The busiest year on record is 2008, with 3. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2007 | 2 |
| 2008 | 3 |
| 2009 | 3 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K092175 | THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 | PDU | Substantially Equivalent | |
| K090621 | FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 | DXT | Substantially Equivalent | |
| K091254 | THE CROSSER 14 OTW CATHETER, MODEL CRU014 | DQY | Substantially Equivalent | |
| K091119 | MODIFICATION TO THE CROSSER SYSTEM | PDU | Substantially Equivalent | |
| K080849 | MICROSHEATH LP AND LP-AT | DQY | Substantially Equivalent | |
| K080765 | CROSSER LP SYSTEM | DQX | Substantially Equivalent | |
| K073289 | MICROSHEATH XL CATHETERS | DQY | Substantially Equivalent | |
| K072776 | THE CROSSER SYSTEM | PDU | Substantially Equivalent | |
| K062868 | THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02 | DQY | Substantially Equivalent | |
| K051580 | VP SHEATH | DQY | Substantially Equivalent | |
| K051062 | VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO | DQX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0938-2011 | Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA Intended use: Catheter for use in surgery. | Mislabeled expiration date: Some units were mislabeled with a three year shelf life, but the product is validated only for a two year shelf life. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain