Cordis Inflator Device
by Cordis Corp.
510(k) K912644
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK912644 | Date16 Sep 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MAV
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1650
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Cordis Inflator Device is a Syringe, Balloon Inflation (product code MAV), classified as a Class II medical device under FDA regulation 870.1650. It is designed for use in balloon inflation procedures, typically within cardiovascular interventions, where precise fluid delivery is required to inflate catheters or balloons for angioplasty or other interventional techniques.
This device is supplied as a single-use, non-sterile item and is intended for use in controlled clinical settings such as catheterization labs. It is regulated under the FDA’s 510(k) clearance pathway, with authorization granted in 1991 (K912644) following a review by the Cardiovascular (CV) Advisory Committee. No additional sterility or MRI safety specifications are noted in the regulatory data.
Other devices from Cordis US Corp.
Questions
AI-generated answers, 18 Sep 2026
What is the Cordis Inflator Device primarily used for in clinical settings?
The Cordis Inflator Device is designed specifically for balloon inflation procedures in cardiovascular interventions. It delivers precise fluid to inflate catheters or balloons during angioplasty or other interventional techniques, ensuring controlled pressure and volume for optimal results in catheterization labs.
Is the Cordis Inflator Device intended for single-use or repeated use?
The Cordis Inflator Device is explicitly supplied as a single-use item, meaning it is intended for one-time use in a controlled clinical setting like a catheterization lab. Reuse is not recommended or supported by the manufacturer.
Is the Cordis Inflator Device sterile, and if not, how should it be handled?
The Cordis Inflator Device is non-sterile as supplied. Since it is intended for use in sterile environments like catheterization labs, it should be handled using standard aseptic techniques, such as cleaning the exterior with an appropriate disinfectant before use, and ensuring the inflation process adheres to sterile field protocols.
What regulatory pathway was followed for FDA clearance of the Cordis Inflator Device?
The Cordis Inflator Device received FDA clearance through the 510(k) pathway, specifically under the Traditional review process, and was deemed Substantially Equivalent (SE) to a predicate device. The clearance was granted in 1991 (K912644) after review by the Cardiovascular (CV) Advisory Committee.
Are there multiple sizes or models of the Cordis Inflator Device, and how can I identify them?
The Cordis Inflator Device is listed under product code MAV (Syringe, Balloon Inflation) with multiple FEI numbers (e.g., 1721676, 1000138054, etc.) in the FDA registry, suggesting variations in design or specifications. While exact sizing details are not provided, these identifiers may correspond to different models or configurations. For precise sizing or model-specific information, refer to the manufacturer’s packaging or technical documentation.