Baxa Corp., Sub. of Cook Group, Inc.
Mchenry, IL, US
Baxa Corp., Sub. of Cook Group, Inc. appears in FDA device records in Mchenry, IL. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Baxa Corp., Sub. of Cook Group, Inc. between 1978 and 1991. The busiest year on record is 1983, with 5. The most recent is 1991, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1981 | 2 |
| 1982 | 1 |
| 1983 | 5 |
| 1985 | 1 |
| 1987 | 2 |
| 1990 | 3 |
| 1991 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K910257 | BAXA PCA INFUSOR | MEA | Substantially Equivalent | |
| K903159 | VALVE CONTROLLER FOR MICROMACRO COMPOUNDER | LHI | Substantially Equivalent | |
| K904225 | KWIKMIX | LHI | Substantially Equivalent | |
| K900585 | TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP | LHI | Substantially Equivalent | |
| K873875 | BAXA EXACTA-MED PHARMACY PUMP | FRN | Substantially Equivalent | |
| K872743 | BAXA TUBING SETS (FOR PHARMACY PUMP) | FMF | Substantially Equivalent | |
| K844904 | CYTOSAFE NEEDLE | LHI | Substantially Equivalent | |
| K832347 | TWOFER NEEDLE | LHI | Substantially Equivalent | |
| K832332 | VENTED I.V. TRANSFER NEEDLE | LHI | Substantially Equivalent | |
| K832312 | I.V. TRANSFER NEEDLE | LHI | Substantially Equivalent | |
| K832254 | BAXA ADDISEAL | KPE | Substantially Equivalent | |
| K832247 | I.V. BAG ADDISEAL | KPE | Substantially Equivalent | |
| K820435 | BAXA ADDISEAL | KPE | Substantially Equivalent | |
| K813435 | BAXA ADLI SEAL | KPE | Substantially Equivalent | |
| K802966 | I.V. ADDITIVE CAP | KPE | Substantially Equivalent | |
| K781364 | PINT BOTTLE WELL | KYX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain