SoftTouch Guide Catheter
510(k) K934685
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK934685 | Date7 Apr 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQY
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The SoftTouch Guide Catheter is a percutaneous catheter classified under product code DQY, designed as a flexible tubular device for intravascular navigation. It serves as a conduit within blood vessels, facilitating the passage of other interventional tools such as guidewires, stents, or balloons during cardiovascular procedures. Its construction prioritises atraumatic insertion and stability within arterial or venous pathways, reducing trauma to vessel walls. The device is intended for use in diagnostic and therapeutic cardiovascular interventions requiring precise catheter placement.
This catheter is supplied as a single-use, sterile medical device, intended for percutaneous insertion via a dilator or introducer sheath. It is regulated under FDA 510(k) clearance (K934685) and falls under the Cardiovascular Device Advisory Committee classification. The device is not MRI-safe, and its dimensions are not specified in the available data. Storage conditions require protection from contamination and physical damage, adhering to standard sterile medical device protocols. No additional regulatory approvals beyond the 510(k) clearance are mentioned.
Other devices from Mallinckrodt Medical
Questions
AI-generated answers, 1 Oct 2026
What is the SoftTouch Guide Catheter used for?
The SoftTouch Guide Catheter is designed as a flexible tubular device for intravascular navigation. It acts as a conduit within blood vessels to guide other interventional tools—such as guidewires, stents, or balloons—during diagnostic and therapeutic cardiovascular procedures. Its atraumatic design minimizes trauma to vessel walls, ensuring stability during precise catheter placement.
Is the SoftTouch Guide Catheter single-use or reusable?
The SoftTouch Guide Catheter is supplied as a single-use device. This design choice ensures sterility and reduces the risk of contamination or cross-infection between patients, adhering to standard medical device protocols for sterile use.
How is the SoftTouch Guide Catheter supplied and prepared for use?
The catheter is supplied sterile and intended for percutaneous insertion via a dilator or introducer sheath. Before use, it must be handled under sterile conditions to prevent contamination. Follow standard sterile medical device protocols for preparation, including checking for physical damage and ensuring proper storage.
What storage conditions are required for the SoftTouch Guide Catheter?
The device must be stored in a clean, dry environment protected from contamination and physical damage. Since it is single-use and sterile, it should remain in its original packaging until immediately before use. Avoid exposure to extreme temperatures or moisture, which could compromise sterility or integrity.
Can the SoftTouch Guide Catheter be used with MRI equipment?
The SoftTouch Guide Catheter is explicitly not MRI-safe. If MRI imaging is required during or after its use, alternative imaging modalities should be considered to avoid potential risks associated with MRI exposure.