Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters

K231015 · Innovative Health, LLC · NLI · Jul 1, 2024 · Cardiovascular

Device Facts

• Record ID: K231015
• Device Name: Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
• Applicant: Innovative Health, LLC
• Product Code: NLI · Cardiovascular
• Decision Date: Jul 1, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

Reprocessed Cordis Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

Device Story

Reprocessed diagnostic angiographic catheters; used to deliver radiopaque contrast medium to vascular sites. Device features braided body and atraumatic tip; available in various French sizes, lengths, and curve configurations. Reprocessed by Innovative Health, LLC; includes removal of visible soil, decontamination, inspection, and functional testing. Device reprocessed maximum one time; serialized and tracked. Used by clinicians in clinical settings to facilitate diagnostic imaging. Output is contrast medium delivery; aids in visualization of vascular anatomy for clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included biocompatibility (cytotoxicity, hemocompatibility, sensitization, irritation, systemic toxicity), cleaning validation, sterilization validation, and functional testing (visual inspection, dimensional verification, radiopacity, simulated use, leak, torsion, tip buckling, tensile, coating coverage, and particulate testing).

Technological Characteristics

Diagnostic angiographic catheters with braided body and atraumatic tip. Materials, design, and function identical to predicate devices. Reprocessing includes cleaning, decontamination, inspection, and functional testing. Sterilization validation performed. No software or energy source.

Indications for Use

Indicated for delivery of radiopaque contrast medium to selected sites in the vascular system.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Cordis 5.0 French Super Torque Catheters (K915836)
• Cordis 5.2 French Super Torque Plus (K914007)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 1, 2024

Innovative Health, LLC. Amanda Babcock Regulatory Affairs Manager 1435 North Hayden Road Suite 100 Scottsdale, Arizona 85257

Re: K231015

Trade/Device Name: Reprocessed Cordis Super Torque and Super Torque Plus Diagnostic Angiographic Catheters Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: NLI Dated: April 7, 2023 Received: April 10, 2023

Dear Amanda Babcock:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Ariel Ariel G. Ash-G. Ash-shakoor -S Date: 2024.07.01 09:21:23 shakoor -S -04'00'

For

Gregory O'Connell

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Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K231015

#### Device Name

Reprocessed Cordis Super Torque and Super Torque Plus Angiographic Diagnostic Catheters

Indications for Use (Describe)

Reprocessed Cordis Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY

#### Submitter's Name and Address:

Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257

## Contact Name and Information:

Meerna Muradvich Regulatory Affairs Engineer Innovative Health, LLC. [phone] (office) [phone] (fax) [e-mail]

Amanda Babcock Regulatory Affairs Manager Innovative Health, LLC. [phone] (office) [phone] (fax) [e-mail]

#### Date prepared:

06/26/2024

## Device Information:

| Trade/Proprietary Name: | Reprocessed Cordis Super Torque and Super<br>Torque Plus Diagnostic Angiographic Catheters |
|-------------------------|--------------------------------------------------------------------------------------------|
| Common Name: | Angiographic Catheter |
| Classification Name: | Catheter, Angiography, Reprocessed |
| Classification Number: | Class II, 21 CFR 870.1200 |
| Product Code: | NLI |

## Predicate Device:

| 510(k) Number | Device | Manufacturer |
|---------------|------------------------------------------|--------------|
| K915836 | Cordis 5.0 French Super Torque Catheters | Cordis Corp. |
| K914007 | Cordis 5.2 French Super Torque Plus | Cordis Corp. |

#### Device Description:

The reprocessed Cordis Catheters are available in a broad variety of French sizes and configurations. These catheters combine an atraumatic tip with a braided body.

The item numbers included in the scope of this submission are as follows:

| Description | Item<br>Number | French<br>Size | Length | Side<br>holes | Curve |
|--------------------------------------------------------------------------------------|----------------|----------------|--------|---------------|---------------------------------------------|
| | 532-410T | 4 | 65 | 8 | PIG |
| | 532-420T | 4 | 65 | 8 | straight |
| | 532-462 | 4 | 65 | 2 | RDCS |
| Description | Item Number | French Size | Length | Side holes | Curve |
| Reprocessed<br>Cordis Super<br>Torque<br>Diagnostic<br>Angiographic<br>Catheter | 532-444 | 4 | 65 | 0 | C3 |
| | 532-445 | 4 | 65 | 2 | C3 |
| | 532-473 | 4 | 65 | 0 | SHK 1 |
| | 532-474 | 4 | 65 | 0 | SHK 2 |
| | 532-447 | 4 | 65 | 0 | JC 1 |
| | 532-448 | 4 | 65 | 0 | JC 2 |
| | 532-449 | 4 | 65 | 0 | JC 3 |
| | SR3740 | 4 | 80 | 0 | JL 1.5 |
| | SRD6054 | 4 | 80 | 0 | JL 2 |
| | SR4533 | 4 | 80 | 0 | JL 2.5 |
| | SRD6920 | 4 | 80 | 4 | PIG 145° |
| | 532-432 | 4 | 80 | 2 | multipurpose small |
| | 532-478 | 4 | 80 | 2 | RDCS |
| | 532-411T | 4 | 90 | 8 | PIG |
| | 532-421T | 4 | 90 | 8 | straight |
| | SRD5816 | 4 | 100 | 0 | IM-MOD-5 |
| | 532-412T | 4 | 100 | 8 | PIG |
| | 532-422T | 4 | 100 | 8 | straight |
| | 532-430 | 4 | 100 | 0 | multipurpose small |
| | 532-482 | 4 | 100 | 2 | multipurpose small |
| | 532-414 | 4 | 100 | 0 | SIM 1 |
| | 532-415 | 4 | 100 | 0 | SIM 2 |
| | 532-461 | 4 | 100 | 0 | H1 |
| | 532-470 | 4 | 100 | 0 | MAN |
| | 532-405 | 4 | 100 | 0 | BERN |
| | 532-436 | 4 | 100 | 0 | JB1 |
| | 532-437 | 4 | 100 | 0 | JB2 |
| | 532-438 | 4 | 100 | 0 | JB3 |
| | 532-497 | 4 | 100 | 0 | VERT |
| | 532-413T | 4 | 110 | 8 | PIG |
| | 532-524V8 | 5 | 65 | 8 | PIG |
| | 532-564V8 | 5 | 65 | 8 | straight |
| | 532-576 | 5 | 65 | 0 | multipurpose (subintimal<br>recanalization) |
| | 532-510 | 5 | 65 | 2 | RDCS |
| | 532-514 | 5 | 65 | 0 | C3 |
| | 532-517 | 5 | 65 | 2 | C3 |
| | 532-519 | 5 | 65 | 0 | SHK 1 |
| | 532-522 | 5 | 65 | 0 | JC 2 |
| | 532-523 | 5 | 65 | 0 | JC 3 |
| | 532-579 | 5 | 80 | 0 | MPA |
| Description | Item<br>Number | French<br>Size | Length | Side<br>holes | Curve |
| | 532-511 | 5 | 80 | 2 | RDCS |
| | 532-509 | 5 | 80 | 0 | RDCA |
| | 532-567 | 5 | 80 | 0 | SHK 2 |
| | 532-539F8 | 5 | 90 | 8 | PIG |
| | 532-555H8 | 5 | 100 | 8 | PIG |
| | 532-569H8 | 5 | 100 | 8 | straight |
| | 532-578 | 5 | 100 | 0 | MPA |
| | 532-501 | 5 | 100 | 0 | SIM 1 |
| | 532-546 | 5 | 100 | 2 | SIM 1 |
| | 532-502 | 5 | 100 | 0 | SIM 2 |
| | 532-547 | 5 | 100 | 2 | SIM 2 |
| | 532-503 | 5 | 100 | 0 | SIM 3 |
| | 532-504 | 5 | 100 | 0 | H1 |
| | 532-520 | 5 | 100 | 0 | HN4 |
| | 532-571 | 5 | 100 | 0 | MAN |
| Reprocessed | 532-541H0 | 5 | 100 | 0 | JB1 |
| Cordis Super | 532-543H0 | 5 | 100 | 0 | JB2 |
| Torque | 532-549H0 | 5 | 100 | 0 | VERT |
| Diagnostic | 455-610T | 6 | 65 | 12 | PIG |
| Angiographic<br>Catheter | 455-672 | 6 | 65 | 0 | C3 |
| | 455-689 | 6 | 80 | 2 | RDCA |
| | 455-698 | 6 | 80 | 4 | NIH |
| | 532-506 | 6 | 80 | 2 | multipurpose small |
| | 455-623 | 6 | 80 | 0 | MPA |
| | 455-636 | 6 | 80 | 2 | MPA |
| | 455-686 | 6 | 80 | 0 | RDCA |
| | 455-611T | 6 | 90 | 12 | PIG |
| | 532-618 | 6 | 100 | 0 | JL 3.5 |
| | 532-620 | 6 | 100 | 0 | JL 4 |
| | 532-627 | 6 | 100 | 0 | JL 4.5 |
| | 532-622 | 6 | 100 | 0 | JL 5 |
| | 532-624 | 6 | 100 | 0 | JL 6 |
| | 532-645 | 6 | 100 | 0 | AL 1 |
| | 532-646 | 6 | 100 | 0 | AL 2 |
| | 532-647 | 6 | 100 | 0 | AL 3 |
| | 532-619 | 6 | 100 | 0 | JR 3.5 |
| | 532-621 | 6 | 100 | 0 | JR 4 |
| | 532-623 | 6 | 100 | 0 | JR 5 |
| | 532-625 | 6 | 100 | 0 | JR 6 |
| | 532-648 | 6 | 100 | 0 | AR MOD |
| | 532-642 | 6 | 100 | 2 | MPA 2 |
| Description | ltem<br>Number | French<br>Size | Length | Side<br>holes | Curve |
| | 532-649 | ర్ | 100 | 2 | MPB 2 |
| | 532-640 | 6 | 100 | 0 | SON 1 |
| | 532-664 | 6 | 100 | 4 | SON 2 |
| | 532-672 | 6 | 100 | 0 | LCB |
| | 532-670 | ರಿ | 100 | 0 | RCB |
| | 532-660 | 6 | 100 | 0 | IM |
| Reprocessed | 455-637 | 6 | 100 | 2 | MPA |
| Cordis Super | 455-660 | 6 | 100 | 0 | SIM 1 |
| Torque | 455-660D | 6 | 100 | 2 | SIM 1 |
| Diagnostic | 455-661 | 6 | 100 | 0 | SIM 2 |
| Angiographic | 455-662 | 6 | 100 | 0 | ടിM 3 |
| Catheter | 455-663 | 6 | 100 | 0 | SIM 4 |
| | 455-665 | 6 | 100 | 0 | H1 |
| | 455-666 | 6 | 100 | 0 | H1 |
| | 532-650S | 6 | 110 | 6 | PIG |
| | 532-652S | 6 | 110 | 6 | PIG 145° |
| | 532-654S | ರಿ | 110 | 6 | PIG 145° MOD |
| | 455-613E | රි | 110 | 8 | PIG |
| Reprocessed | 533-562 | 5.2 | 65 | 2 | MPA 2 |
| Cordis Super | 533-579 | 5.2 | 80 | 0 | MPA |
| Torque Plus<br>Diagnostic | SR3216 | 5.2 | 100 | 0 | JL 3 |
| Angiographic | 533-551 | 5.2 | 100 | 0 | JL 3.5 |
| Catheter | 233-223 | 5.2 | 100 | 0 | JL 4 |
| | 533-527 | 5.2 | 100 | 0 | JL 4.5 |
| | 233-229 | 5.2 | 100 | 0 | ി 5 |
| | 533-561 | 5.2 | 100 | 0 | JL 6 |
| | 533-542 | 5.2 | 100 | 0 | AL 2 |
| | 533-544 | 5.2 | 100 | O | AL 3 |
| | SR4615 | 5.2 | 100 | O | XB 3.5 ST |
| | 233-250 | 5.2 | 100 | O | JR 3.5 |
| | 533-552 | 5.2 | 100 | O | JR 4 |
| | 533-528 | 5.2 | 100 | 0 | JR 4 MOD |
| | 533-563 | 5.2 | 100 | 0 | JR 4 ST |
| | 533-558 | 5.2 | 100 | 0 | JR 5 |
| | 533-560 | 5.2 | 100 | O | JR 6 |
| | SR1924 | 5.2 | 100 | O | MPA |
| | 533-582 | 5.2 | 100 | 2 | MPA 2 |
| | 533-584 | 5.2 | 100 | O | CAS 1 |
| | 533-585 | 5.2 | 100 | 0 | CAS 2 |
| | 59950072 | 5.2 | 100 | 2 | RBL-JK |
| | 599500T1 | 5.2 | 100 | 1 | RBL-TG |
| Description | Item<br>Number | French<br>Size | Length | Side<br>holes | Curve |
| | 533-572 | 5.2 | 100 | 0 | LCB |
| | 533-570 | 5.2 | 100 | 0 | RCB |
| | 533-580 | 5.2 | 100 | 0 | IM |
| | SR4658 | 5.2 | 100 | 0 | IM-MOD |
| | SR4268 | 5.2 | 100 | 0 | IM-MOD-2 |
| | SR4685 | 5.2 | 100 | 0 | IM-MOD-3 |
| | 533-533 | 5.2 | 110 | 6 | PIG |
| | 533-534A | 5.2 | 110 | 6 | PIG 145° |
| Reprocessed<br>Cordis Super<br>Torque Plus<br>Diagnostic<br> | 533-537S | 5.2 | 110 | 6 | PIG 145° MOD |
| | 533-533A | 5.2 | 110 | 6 | PIG 155° |
| | 533-633 | 6 | 80 | 0 | MPA 1 |
| | 533-629 | 6 | 80 | 2 | MPA 2 |
| | 533-682 | 6 | 80 | 4 | CAS 2 |
| | 533-635 | 6 | 80 | 0 | NIH |
| | 533-618 | 6 | 100 | 0 | JL 3.5 |
| | 533-620 | 6 | 100 | 0 | JL 4 |
| | 533-627 | 6 | 100 | 0 | JL 4.5 |
| | 533-622 | 6 | 100 | 0 | JL 5 |
| | 533-624 | 6 | 100 | 0 | JL 6 |
| | 533-645 | 6 | 100 | 0 | AL 1 |
| | 533-646 | 6 | 100 | 0 | AL 2 |
| | 533-647 | 6 | 100 | 0 | AL 3 |
| | 533-619 | 6 | 100 | 0 | JR 3.5 |
| | 533-621 | 6 | 100 | 2 | JR 3.5 |
| | 533-687 | 6 | 100 | 0 | JR 4 CLASSIC |
| | 533-689 | 6 | 100 | 0 | JR 4 RECESSED<br>BRAIDING |
| | 533-628 | 6 | 100 | 0 | JR 4 MOD |
| | 533-626 | 6 | 100 | 0 | JR 4 ST |
| | 533-623 | 6 | 100 | 0 | JR 5 |
| | 533-625 | 6 | 100 | 0 | JR 6 |
| | 533-648 | 6 | 100 | 0 | AR MOD |
| | 533-641 | 6 | 100 | 0 | AR 1 MOD |
| | 533-643 | 6 | 100 | 0 | AR 2 MOD |
| | 533-640 | 6 | 100 | 0 | MPA 1 COURNAD |
| | 533-642 | 6 | 100 | 2 | MPA 2 |
| | 533-649 | 6 | 100 | 2 | MPB 2 |
| | 533-634 | 6 | 100 | 6 | MPB 3 |
| | 533-630 | 6 | 100 | 4 | SON 1 |
| | 533-631 | 6 | 100 | 0 | SON 2 |
| | 533-632 | 6 | 100 | 4 | SON 3 |
| Description | Item<br>Number | French<br>Size | Length | Side<br>holes | Curve |
| Reprocessed<br>Cordis Super<br>Torque Plus<br>Diagnostic<br>Angiographic<br>Catheter | 533-684 | 6 | 100 | 0 | CAS 1 |
| | 533-685 | 6 | 100 | 0 | CAS 2 |
| | 533-686 | 6 | 100 | 0 | CAS 3 |
| | 599600R401 | 6 | 100 | 1 | RBL 4.0 |
| | 599600R451 | 6 | 100 | 1 | RBL 4.5 |
| | 599600R501 | 6 | 100 | 1 | RBL 5.0 |
| | 599600J2 | 6 | 100 | 2 | RBL-JK |
| | 599600T1 | 6 | 100 | 1 | RBL-TG |
| | 533-637 | 6 | 100 | 0 | EGB 1 |
| | 533-638 | 6 | 100 | 0 | EGB 2 |
| | 533-672 | 6 | 100 | 0 | LCB |
| | 533-670 | 6 | 100 | 0 | RCB |
| | 533-660 | 6 | 100 | 0 | IM |
| | 533-636 | 6 | 100 | 0 | NIH |
| | 533-650F | 6 | 110 | 4 | PIG |
| | 533-650S | 6 | 110 | 6 | PIG |
| | 533-650E | 6 | 110 | 8 | PIG |
| | 533-652S | 6 | 110 | 6 | PIG 145° |
| | 533-653S | 6 | 110 | 6 | PIG 145° MOD |
| | 533-654S | 6 | 110 | 6 | PIG 155° |
| | 533-655S | 6 | 110 | 6 | PIG 155° MOD |

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Table 1: Device Scope

## Indications for Use:

Reprocessed Cordis Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

## Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Cordis Super Torque and Super Torque Plus diagnostic angiographic catheters are identical to the predicate devices. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of these devices includes removal of visible soil and decontamination. Each device is inspected and function tested prior to packaging and labeling.

## Functional and Safety Testing:

Bench and laboratory testing was conducted to demonstrate substantially equivalent performance of the Reprocessed Cordis Super Torque and Super Torque Plus Catheters. This included the following:

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- Biocompatibility ●
- Cytotoxicity .
- Hemocompatibility
- Sensitization
- . Irritation
- . Systemic Toxicitv
- Cleaning Validation ●
- Sterilization Validation
- Functional testing ●
- Visual Inspection .
- . Dimensional Verification
- l Radiopacity Testing
- l Simulated Use Testing
- . Leak Testing
- I Torsion Testing
- Tip Buckling Testing I
- 트 Tensile Testing
- . Coating Coverage
- . Particulate Testing
- . Packaging Validation

The Reprocessed Cordis Super Torque and Super Torque Plus Catheters are reprocessed no more than one (1) time. Each device is marked, serialized and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

# Conclusion:

Innovative Health concludes that the Reprocessed Cordis Super Torque and Super Torque Plus Diagnostic Angiographic catheters do not raise new questions of safety and effectiveness and supports substantial equivalence to the predicate devices described herein.

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| Description | Item<br>Number | French<br>Size | Length | Side<br>holes | Curve |
|--------------------------------------------------------------------------------------|----------------|----------------|--------|---------------|---------------------------------------------|
| | 532-410T | 4 | 65 | 8 | PIG |
| | 532-420T | 4 | 65 | 8 | straight |
| | 532-462 | 4 | 65 | 2 | RDCS |
| | 532-444 | 4 | 65 | 0 | C3 |
| | 532-445 | 4 | 65 | 2 | C3 |
| | 532-473 | 4 | 65 | 0 | SHK 1 |
| | 532-474 | 4 | 65 | 0 | SHK 2 |
| | 532-447 | 4 | 65 | 0 | JC 1 |
| | 532-448 | 4 | 65 | 0 | JC 2 |
| | 532-449 | 4 | 65 | 0 | JC 3 |
| | SR3740 | 4 | 80 | 0 | JL 1.5 |
| | SRD6054 | 4 | 80 | 0 | JL 2 |
| | SR4533 | 4 | 80 | 0 | JL 2.5 |
| | SRD6920 | 4 | 80 | 4 | PIG 145° |
| | 532-432 | 4 | 80 | 2 | multipurpose small |
| | 532-478 | 4 | 80 | 2 | RDCS |
| | 532-411T | 4 | 90 | 8 | PIG |
| | 532-421T | 4 | 90 | 8 | straight |
| Reprocessed<br>Cordis Super<br>Torque<br>Diagnostic<br>Angiographic<br>Catheter | SRD5816 | 4 | 100 | 0 | IM-MOD-5 |
| | 532-412T | 4 | 100 | 8 | PIG |
| | 532-422T | 4 | 100 | 8 | straight |
| | 532-430 | 4 | 100 | 0 | multipurpose small |
| | 532-482 | 4 | 100 | 2 | multipurpose small |
| | 532-414 | 4 | 100 | 0 | SIM 1 |
| | 532-415 | 4 | 100 | 0 | SIM 2 |
| | 532-461 | 4 | 100 | 0 | H1 |
| | 532-470 | 4 | 100 | 0 | MAN |
| | 532-405 | 4 | 100 | 0 | BERN |
| | 532-436 | 4 | 100 | 0 | JB1 |
| | 532-437 | 4 | 100 | 0 | JB2 |
| | 532-438 | 4 | 100 | 0 | JB3 |
| | 532-497 | 4 | 100 | 0 | VERT |
| | 532-413T | 4 | 110 | 8 | PIG |
| | 532-524V8 | 5 | 65 | 8 | PIG |
| | 532-564V8 | 5 | 65 | 8 | straight |
| | 532-576 | 5 | 65 | 0 | multipurpose (subintimal<br>recanalization) |
| | 532-510 | 5 | 65 | 2 | RDCS |
| Description | Item<br>Number | French<br>Size | Length | Side<br>holes | Curve |
| | 532-514 | 5 | 65 | 0 | C3 |
| | 532-517 | 5 | 65 | 2 | C3 |
| | 532-519 | 5 | 65 | 0 | SHK 1 |
| | 532-522 | 5 | 65 | 0 | JC 2 |
| | 532-523 | 5 | 65 | 0 | JC 3 |
| | 532-579 | 5 | 80 | 0 | MPA |
| | 532-511 | 5 | 80 | 2 | RDCS |
| | 532-509 | 5 | 80 | 0 | RDCA |
| | 532-567 | 5 | 80 | 0 | SHK 2 |
| | 532-539F8 | 5 | 90 | 8 | PIG |
| | 532-555H8 | 5 | 100 | 8 | PIG |
| | 532-569H8 | 5 | 100 | 8 | straight |
| | 532-578 | 5 | 100 | 0 | MPA |
| | 532-501 | 5 | 100 | 0 | SIM 1 |
| | 532-546 | 5 | 100 | 2 | SIM 1 |
| | 532-502 | 5 | 100 | 0 | SIM 2 |
| | 532-547 | 5 | 100 | 2 | SIM 2 |
| | 532-503 | 5 | 100 | 0 | SIM 3 |
| | 532-504 | 5 | 100 | 0 | H1 |
| | 532-520 | 5 | 100 | 0 | HN4 |
| Reprocessed<br>Cordis Super<br>Torque<br>Diagnostic<br>Angiographic<br>Catheter | 532-571 | 5 | 100 | 0 | MAN |
| | 532-541H0 | 5 | 100 | 0 | JB1 |
| | 532-543H0 | 5 | 100 | 0 | JB2 |
| | 532-549H0 | 5 | 100 | 0 | VERT |
| | 455-610T | 6 | 65 | 12 | PIG |
| | 455-672 | 6 | 65 | 0 | C3 |
| | 455-689 | 6 | 80 | 2 | RDCA |
| | 455-698 | 6 | 80 | 4 | NIH |
| | 532-506 | 6 | 80 | 2 | multipurpose small |
| | 455-623 | 6 | 80 | 0 | MPA |
| | 455-636 | 6 | 80 | 2 | MPA |
| | 455-686 | 6 | 80 | 0 | RDCA |
| | 455-611T | 6 | 90 | 12 | PIG |
| | 532-618 | 6 | 100 | 0 | JL 3.5 |
| | 532-620 | 6 | 100 | 0 | JL 4 |
| | 532-627 | 6 | 100 | 0 | JL 4.5 |
| | 532-622 | 6 | 100 | 0 | JL 5 |
| | 532-624 | 6 | 100 | 0 | JL 6 |
| | 532-645 | 6 | 100 | 0 | AL 1 |
| | 532-646 | 6 | 100 | 0 | AL 2 |
| Description | Item<br>Number | French<br>Size | Length | Side<br>holes | Curve |
| Reprocessed<br>Cordis Super<br>Torque<br>Diagnostic<br>Angiographic<br>Catheter | 532-647 | 6 | 100 | 0 | AL 3 |
| | 532-619 | 6 | 100 | 0 | JR 3.5 |
| | 532-621 | 6 | 100 | 0 | JR 4 |
| | 532-623 | 6 | 100 | 0 | JR 5 |
| | 532-625 | 6 | 100 | 0 | JR 6 |
| | 532-648 | 6 | 100 | 0 | AR MOD |
| | 532-642 | 6 | 100 | 2 | MPA 2 |
| | 532-649 | 6 | 100 | 2 | MPB 2 |
| | 532-640 | 6 | 100 | 0 | SON 1 |
| | 532-664 | 6 | 100 | 4 | SON 2 |
| | 532-672 | 6 | 100 | 0 | LCB |
| | 532-670 | 6 | 100 | 0 | RCB |
| | 532-660 | 6 | 100 | 0 | IM |
| | 455-637 | 6 | 100 | 2 | MPA |
| | 455-660 | 6 | 100 | 0 | SIM 1 |
| | 455-660D | 6 | 100 | 2 | SIM 1 |
| | 455-661 | 6 | 100 | 0 | SIM 2 |
| | 455-662 | 6 | 100 | 0 | SIM 3 |
| | 455-663 | 6 | 100 | 0 | SIM 4 |
| | 455-665 | 6 | 100 | 0 | H1 |
| | 455-666 | 6 | 100 | 0 | H1 |
| | 532-650S | 6 | 110 | 6 | PIG |
| | 532-652S | 6 | 110 | 6 | PIG 145° |
| | 532-654S | 6 | 110 | 6 | PIG 145° MOD |
| | 455-613E | 6 | 110 | 8 | PIG |
| Reprocessed<br>Cordis Super<br>Torque Plus<br>Diagnostic<br>Angiographic<br>Catheter | 533-562 | 5.2 | 65 | 2 | MPA 2 |
| | 533-579 | 5.2 | 80 | 0 | MPA |
| | SR3216 | 5.2 | 100 | 0 | JL 3 |
| | 533-551 | 5.2 | 100 | 0 | JL 3.5 |
| | 533-553 | 5.2 | 100 | 0 | JL 4 |
| | 533-527 | 5.2 | 100 | 0 | JL 4.5 |
| | 533-559 | 5.2 | 100 | 0 | JL 5 |
| | 533-561 | 5.2 | 100 | 0 | JL 6 |
| | 533-542 | 5.2 | 100 | 0 | AL 2 |
| | 533-544 | 5.2 | 100 | 0 | AL 3 |
| | SR4615 | 5.2 | 100 | 0 | XB 3.5 ST |
| | 533-550 | 5.2 | 100 | 0 | JR 3.5 |
| | 533-552 | 5.2 | 100 | 0 | JR 4 |
| | 533-528 | 5.2 | 100 | 0 | JR 4 MOD |
| | 533-563 | 5.2 | 100 | 0 | JR 4 ST |
| Description | Item Number | French Size | Length | Side holes | Curve |
| | 533-558 | 5.2 | 100 | 0 | JR 5 |
| | 533-560 | 5.2 | 100 | 0 | JR 6 |
| | SR1924 | 5.2 | 100 | 0 | MPA |
| | 533-582 | 5.2 | 100 | 2 | MPA 2 |
| | 533-584 | 5.2 | 100 | 0 | CAS 1 |
| | 533-585 | 5.2 | 100 | 0 | CAS 2 |
| | 599500J2 | 5.2 | 100 | 2 | RBL-JK |
| | 599500T1 | 5.2 | 100 | 1 | RBL-TG |
| | 533-572 | 5.2 | 100 | 0 | LCB |
| | 533-570 | 5.2 | 100 | 0 | RCB |
| | 533-580 | 5.2 | 100 | 0 | IM |
| | SR4658 | 5.2 | 100 | 0 | IM-MOD |
| | SR4268 | 5.2 | 100 | 0 | IM-MOD-2 |
| | SR4685 | 5.2 | 100 | 0 | IM-MOD-3 |
| | 533-533 | 5.2 | 110 | 6 | PIG |
| | 533-534A | 5.2 | 110 | 6 | PIG 145° |
| Reprocessed<br>Cordis Super<br>Torque Plus<br>Diagnostic<br>Angiographic<br>Catheter | 533-537S | 5.2 | 110 | 6 | PIG 145° MOD |
| | 533-533A | 5.2 | 110 | 6 | PIG 155° |
| | 533-633 | 6 | 80 | 0 | MPA 1 |
| | 533-629 | 6 | 80 | 2 | MPA 2 |
| | 533-682 | 6 | 80 | 4 | CAS 2 |
| | 533-635 | 6 | 80 | 0 | NIH |
| | 533-618 | 6 | 100 | 0 | JL 3.5 |
| | 533-620 | 6 | 100 | 0 | JL 4 |
| | 533-627 | 6 | 100 | 0 | JL 4.5 |
| | 533-622 | 6 | 100 | 0 | JL 5 |
| | 533-624 | 6 | 100 | 0 | JL 6 |
| | 533-645 | 6 | 100 | 0 | AL 1 |
| | 533-646 | 6 | 100 | 0 | AL 2 |
| | 533-647 | 6 | 100 | 0 | AL 3 |
| | 533-619 | 6 | 100 | 0 | JR 3.5 |
| | 533-621 | 6 | 100 | 2 | JR 3.5 |
| | 533-687 | 6 | 100 | 0 | JR 4 CLASSIC<br>JR 4 RECESSED |
| | 533-689 | 6 | 100 | 0 | BRAIDING |
| | 533-628 | 6 | 100 | 0 | JR 4 MOD |
| | 533-6…