Novosci Corp
Conroe, TX, US
NOVOSCI CORP. appears in FDA device records in Conroe, TX. FDA records list 4 510(k) clearances between and , 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
FDA records under these names
1 nameFDA records resolved to Novosci Corp 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.
- Dokitz NovoScienforcement report, recall
510(k) clearance history
FDA records hold 4 510(k) clearances for Novosci Corp between 2004 and 2007. The busiest year on record is 2004, with 2. The most recent is 2007, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 2 |
| 2007 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K072499 | NOVOFLO CATHETER LT | MSD | Unknown | |
| K063355 | D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW | MPB | Unknown | |
| K033270 | NOVOSCI READY SYSTEM, MODEL RS-200 | KFM | Substantially Equivalent | |
| K033328 | NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT | DTL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1625519 | 1625519 | NOVOSCI CORP. | 2021 Airport Road, Conroe, TX 77301 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- KRIAccessory Equipment, Cardiopulmonary Bypass
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- MSDCatheter, Hemodialysis, Implanted
- MPBCatheter, Hemodialysis, Non-Implanted
- DXCClamp, Vascular
- DTPDefoamer, Cardiopulmonary Bypass
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DWSInstruments, Surgical, Cardiovascular
- DTZOxygenator, Cardiopulmonary Bypass
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DTNReservoir, Blood, Cardiopulmonary Bypass
- DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0178-2015 | 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. | Class II | Terminated | |
| Z-0281-04 | Pediatric Air Aspirator Needle manufactured by Novosci Corp., The Woodlands, TX | The firm packaged Modified Air Aspirator Needles into Pediatric Air Aspirator Needle boxes. | Terminated |
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.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Novosci Corp edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain