Data / Medical devices / United States / Novosci Corp.
Novosci Corp.: FDA-registered device maker in Conroe, TX, United States, 18 510(k) clearances
Novosci Corp. is registered with the FDA (registration 1625519) in Conroe, TX, United States. It lists 12 device types. The FDA files 18 510(k) clearances under its listings, the newest dated March 9, 1999. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1625519
- Address
- 2021 Airport Road, Conroe, TX, United States, 77301
- Owner or operator
- NOVOSCI CORP. (9057741)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 18, 1998
- Registered through
- 2027
- Brand names listed
- CARDIOPULMONARY ACCESSORIES, CARDIOPULMONARY BYPASS ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS ADAPTOR, STOPCOCK AND MANIFOLD FITTING, CARDIOPULMONARY BYPASS ARTERIAL LINE BLOOD FILTER, CARDIOPULMONARY BYPASS BLOOD RESERVOIR, CARDIOPULMONARY BYPASS CARDIOTOMY RETURN SUCKER, CARDIOPULMONARY BYPASS CATHETER, CANNULA AND VASCULAR TUBING, CARDIOPULMONARY BYPASS OXYGENATOR (stopcock accessory) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 9, 1999 | K990514 | MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR | DTP | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 27, 1982 | K821495 | DISPOSABLE BLOOD LINE CONNECTORS | KOC | Substantially Equivalent | Bentley Laboratories, Inc. | accessdata.fda.gov |
| March 15, 1982 | K820472 | WILLIAM HARVEY H-625 ARTERIAL FILTER | DTM | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 23, 1981 | K810532 | DISPOSABLE STOPCOCK | DTZ | Substantially Equivalent | Texas Medical Products, Inc. | accessdata.fda.gov |
| January 16, 1981 | K802545 | CARDIOPLEGIC SETS | DTR | Substantially Equivalent | Texas Medical Products, Inc. | accessdata.fda.gov |
| January 16, 1981 | K802542 | DISPOSABLE CONNECTORS | KRI | Substantially Equivalent | Texas Medical Products, Inc. | accessdata.fda.gov |
| January 16, 1981 | K802541 | DISPOSABLE PARALLEL Y CONNECTORS | KRI | Substantially Equivalent | Texas Medical Products, Inc. | accessdata.fda.gov |
| June 30, 1980 | K801405 | DISPOSABLE PERFUSION CONNECTORS | DTL | Substantially Equivalent | Texas Medical Products, Inc. | accessdata.fda.gov |
| June 30, 1980 | K801404 | DISPOSABLE PARALLEL Y CONNECTORS | DTL | Substantially Equivalent | Texas Medical Products, Inc. | accessdata.fda.gov |
| June 30, 1980 | K801403 | DISPOSABLE PERFUSION SET | DWF | Substantially Equivalent | Texas Medical Products, Inc. | accessdata.fda.gov |
| June 30, 1980 | K801402 | QUICKIE PRIME CARDIOP. BYPASS PERF. INTR | DTL | Substantially Equivalent | Texas Medical Products, Inc. | accessdata.fda.gov |
| June 30, 1980 | K801401 | CARDIOPULMONARY BYPASS TUBING | DWF | Substantially Equivalent | Texas Medical Products, Inc. | accessdata.fda.gov |
| June 30, 1980 | K801400 | DISPOSABLE SUCKER SYSTEM | DTS | Substantially Equivalent | Texas Medical Products, Inc. | accessdata.fda.gov |
| June 30, 1980 | K801399 | CORONARY PERFUSION CONNECTOR PLUG | DTL | Substantially Equivalent | Texas Medical Products, Inc. | accessdata.fda.gov |
| June 30, 1980 | K801396 | SAPHENOUS VEIN CANNULAE | DWF | Substantially Equivalent | Texas Medical Products, Inc. | accessdata.fda.gov |
| June 30, 1980 | K801395 | VASCULAR CLAMP | DXC | Substantially Equivalent | Texas Medical Products, Inc. | accessdata.fda.gov |
| June 30, 1980 | K801393 | AIR ASPIRATOR NEEDLE | DWS | Substantially Equivalent | Texas Medical Products, Inc. | accessdata.fda.gov |
| June 30, 1980 | K801392 | DISPOSABLE SUMP SETS | DWF | Substantially Equivalent | Texas Medical Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 18, 2014 | 69535 | Class II | Terminated | Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014 | The single leg of the PAY connector has been observed to become detached. | accessdata.fda.gov |
| November 24, 2003 | 27783 | Not yet classified | Terminated | Pediatric Air Aspirator Needle manufactured by Novosci Corp., The Woodlands, TX | The firm packaged Modified Air Aspirator Needles into Pediatric Air Aspirator Needle boxes. | accessdata.fda.gov |
Compare with other makers
- All makers of Oxygenator, Cardiopulmonary Bypass
- All makers of Clamp, Vascular
- All makers of Filter, Blood, Cardiopulmonary Bypass, Arterial Line
- All makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- All makers of Accessory Equipment, Cardiopulmonary Bypass
- All makers of Defoamer, Cardiopulmonary Bypass
Updated November 6, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.