Titan Micro Catheter, Model 105-5074-153; HD Injector, Model 103-0305
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K022003 FDA 510(k)
- FDA Product Code
- DYB FDA 510(k)
- Models / Variants
- Titan Micro Catheter, Model 105-5074-153 FDA 510(k)Hd Injector, Model 103-0305 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1340 FDA 510(k)
- Regulation Number
- 870.1340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Titan Micro Catheter, Model 105-5074-153, is an end-hole, single-lumen catheter classified under the product code DYB (Introducer, Catheter). Designed for vascular access, it enables controlled selective infusion of therapeutic agents or contrast media into peripheral and neurovascular anatomy. The accompanying HD Injector, Model 103-0305, facilitates precise fluid delivery when paired with the catheter. Both components are intended for use in interventional radiology and neurovascular procedures.
This device is supplied as a reusable system, intended for single-patient use per procedure. It is not MRI-safe and must be used in environments compliant with sterile technique. The Titan Micro Catheter and HD Injector combination received FDA 510(k) clearance under the Cardiovascular (CV) Advisory Committee in 2002, classified as Class II with Special Controls. No additional sterility or regulatory markings beyond the stated clearance are provided in the specifications.
Frequently asked questions
What is the Titan Micro Catheter 105-5074-153 with HD Injector 103-0305 used for?
This system combines an end-hole, single-lumen catheter (Model 105-5074-153) with an HD Injector (Model 103-0305) to enable controlled, selective infusion of therapeutic agents or contrast media. It is specifically designed for vascular access in peripheral and neurovascular procedures, ensuring precise delivery during interventional radiology or neurovascular interventions.
Is the Titan Micro Catheter system reusable or single-use?
The system is intended for single-patient use per procedure despite being reusable. This means each catheter and injector combination is dedicated to one patient’s procedure, even though the components themselves may be reused across multiple procedures after proper cleaning and maintenance. The design ensures sterility and safety for each use.
How is the Titan Micro Catheter system supplied, and what sterility precautions are required?
The system is supplied as a reusable kit but must be used under sterile technique for each procedure. Since it is not pre-sterilized for single-use, clinicians must adhere to strict aseptic protocols before use. The manufacturer does not specify additional sterility markings beyond the FDA 510(k) clearance, so facility-specific sterilization procedures apply.
Can this system be used in MRI environments?
No, the Titan Micro Catheter and HD Injector combination is not MRI-safe. It must only be used in environments where MRI compatibility is not required, such as standard interventional radiology or neurovascular labs. Always verify facility protocols before use.
What regulatory pathway does this device follow, and when was it cleared?
The device received FDA 510(k) clearance under the Cardiovascular (CV) Advisory Committee in 2002. It was classified as Class II with Special Controls and determined to be substantially equivalent to a predicate device. The clearance was granted via a traditional 510(k) review process, with no additional regulatory markings provided beyond the stated authorization.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Titan Micro Catheter, Model 105-5074-153; Hd Injector, Model 103-0305 ..., K022003 - TITAN MICRO CATHETER | FDA 510 (k), PDF Titan Micro Catheter, Model 105-5074-153; Hd Injector, Model 103-0305 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K022003 | Class II | Active |
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Manufacturer
- Manufacturer
- Micro Therapeutics, Inc.
Sources (1)
- FDA 510(k) K022003 24 fields · synced Oct 1, 2026