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510(k) Data Aggregation
K Number
K233637Device Name
Cordis BRITECROSS Support Catheter
Manufacturer
Cordis US Corp.
Date Cleared
2024-06-28
(228 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Cordis US Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cordis BRITECROSS Support Catheters are indicated to guide and support a guide wire during access to the peripheral vasculature, allow for exchange of guide wires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Device Description
The BRITECROSS Support Catheter is a flexible single lumen catheter that is intended to cross lesions to facilitate guidewire access and/or the delivery of saline/contrast during peripheral vascular interventions. The subject device is designed to allow for fluoroscopic visualization of the catheter. The radiopaque distal tip allows for accurate placement of the tip relative to the lesion. Further, there are two (2) radiopaque marker bands incorporated along the shaft to provide the clinician with a length reference facilitating approximation of the lesion length. On the proximal end, the hub has an integrated strain relief and a standard female luer to connect with a standard syringe. The BRITECROSS Catheter is available in various lengths and diameters and the size is printed on the hub for quick identification. The device is sterile and is for single use.
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K Number
K232573Device Name
INFINITI Ambi Angiographic Catheter
Manufacturer
Cordis US Corp.
Date Cleared
2023-11-21
(88 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
Cordis US Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cordis catheters are indicated for enabling diagnosis of various pathologies by facilitating of diagnostic devices within the coronary and peripheral vasculature.
Device Description
The INFINITI Ambi Catheter is a 0.038" guidewire compatible catheter with a 3-staged braided nylon construction. The body is a braided nylon intended for torque responsiveness and stability. The proximal segment is a non-braided nylon for flexibility and shape retention. The Distal Tip is a soft, radiopaque nylon for minimal vessel cannulation. The INFINITI Ambi product line comes in 5F and 6F size and various curve style configurations. The device is a disposable intended for single use only. It is individually packaged and sterilized by ethylene oxide gas.
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K Number
K230704Device Name
RAIN Sheath Tibial Pedal Introducer
Manufacturer
Cordis US Corp.
Date Cleared
2023-04-24
(41 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
Cordis US Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RAIN SheathTM Tibial Pedal Introducer is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee.
Device Description
The RAIN Sheath™ Tibial Pedal Introducer device (hereafter referred as RAIN Sheath™ Pedal) consists of a sheath introducer, a vessel dilator (0.021" guidewire compatible), a stainless-steel entry needle, and a 0.021" guidewire (either stainless steel or nitinol). The sheath introducer has a lubricious hydrophilic coating, a smooth shoulder transition to the dilator and low-profile outer diameters (OD). To provide an atraumatic transition between the dilator tip and the 0.021" mini guide wire, the RAIN Sheath™ dilator is tapered at the distal end and the inner diameter (ID) of the dilator has been optimized. The hub is overmolded to the dilator and includes a locking mechanism between the hub of the vessel dilator and the hub of the sheath cannula to facilitate insertion of the product while preventing the vessel dilator from backing out of the cannula. The RAIN Sheath™ Pedal device is available in four (4) product configurations which differ based on the French sizes (4F and 5F) and specific wire included in the system. RAIN Sheath™ Pedal is a single-use sterile device, sterilized by ethylene oxide.
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K Number
K221832Device Name
SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter
Manufacturer
Cordis US Corp.
Date Cleared
2022-08-22
(60 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Cordis US Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SABER™ .014 and SABERX™ .014 PTA Dilatation Catheters are intended to dilate stenoses in the peripheral vasculature, including femoral, popliteal and infra popliteal arteries. The device is also indicated for post-dilation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Device Description
The SABER™ .014 and SABERX™ .014 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter are single-use sterile devices, sterilized by ethylene oxide.
The SABER™ .014 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is an over-the-wire (OTW) coaxial lumen catheter with a semi-compliant balloon mounted on its distal end. It is compatible with 0.014" (0.3556 mm) guidewire. The catheter is available in working lengths of 90 cm and 150 cm with balloon diameters ranging from 1.25 mm to 5.0 mm, and balloon lengths ranging from 15 mm to 300 mm.
Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. For balloon lengths greater than or equal to 100 mm, the distal section will have two (2) adjacent marker bands and the proximal section will have one (1) marker band. For balloon lengths less than 100 mm, the distal and proximal section will each have one (1) marker band. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses. SABER™ .014 balloons are coated with a dual-layer hydrophilic material designed to increase lubricity throughout the lifetime of the device.
The working pressure range for the balloon is between the nominal pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. Consult the compliance chart on the tray label for typical diameters of the balloons at given pressures.
The balloon lumen is used to inflate and deflate the balloon. The nominal balloon size in printed on the hub. The guidewire lumen is used to track the catheter over a prepositioned guidewire.
The radiopaque marker bands (the length between the outer edge of most proximal to the outer edge of most distal marker band) indicate the stated nominal length of the balloon.
The SABERX™ .014 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a catheter with a distal inflatable balloon. The catheter is available in working lengths of 90 cm, 150 cm and 200 cm with balloon diameters ranging from 1.25 mm to 6.0 mm, and balloon lengths ranging from 15 mm to 300 mm. The catheter utilizes a Rapid Exchange design, consisting of a single inflation lumen and a distal guidewire lumen. The guidewire lumen begins at the distal tip and terminates at the guidewire exit port. The proximal hub is used as a balloon inflation port.
Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. For balloon lengths greater than or equal to 100 mm, the distal section will have two (2) adjacent marker bands and the proximal section will have one (1) marker band. For balloon lengths less than 100 mm, the distal and proximal section will each have one (1) marker band. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses. SABERX™ .014 balloons are coated with a dual-layer hydrophilic material designed to increase lubricity throughout the lifetime of the device.
The working pressure range for the balloon is between the nominal pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. Consult the compliance chart on the tray label for typical diameters of the balloons at given pressures.
The radiopaque marker bands (the length between the outer edge of most proximal to the outer edge of most distal marker band) indicate the stated nominal length of the balloon.
The associated accessories for SABERX™ .014 PTA Dilatation Catheter include:
- Flushing Needle
The SABER™ .014 and SABERX™ .014 PTA Dilatation Catheter are for use in a catherization lab, hospital or other suitable healthcare facility by appropriately trained medical professionals only.
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