Unimpregnated Central Venous Catheter

K260165 · Spectrum Vascular · FOZ · Aug 10, 2026 · General Hospital

Device Facts

• Record ID: K260165
• Device Name: Unimpregnated Central Venous Catheter
• Applicant: Spectrum Vascular
• Product Code: FOZ · General Hospital
• Decision Date: Aug 10, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for: 1. Continuous or intermittent drug infusions 2. Central venous blood pressure monitoring (CVP) 3. Acute hyperalimentation 4. Blood sampling 5. Delivery of whole blood or blood products 6. Simultaneous, separate infusion of drugs for multi-lumen catheters only The device is a short-term use catheter, intended for less than 30 days. The Cook dilator is used for dilating puncture sites or catheter tracts. The Unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations. The Unimpregnated Central Venous Catheter with Power Injection is used for: 1. Continuous or intermittent drug infusions 2. Central venous blood pressure monitoring (CVP) 3. Acute hyperalimentation 4. Blood sampling 5. Delivery of whole blood or blood products 6. Simultaneous, separate infusion of drugs for multi-lumen catheters only 7. Power injection of contrast media* *The flow rate may not exceed 3 mL/sec for 4.0 and 5.0 French catheters and 10 mL/sec for 7.0, 8.0, 9.0 and 10.0 French catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0 and 10.0 French catheters. The device is a short-term use catheter, intended for less than 30 days. The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter. The Cook dilator is used for dilating puncture sites or catheter tracts. The Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations.

Device Story

Central venous catheter (CVC) for short-term vascular access; inserted via Seldinger technique; tip positioned at SVC-RA junction. Available in single, double, triple, or five-lumen configurations; sizes 2.5-10 French. Used for drug infusion, blood monitoring, sampling, and hyperalimentation. Power-injectable models support contrast media delivery at defined flow/pressure limits. Includes wire guide, access needle, and optional accessories like dilators. Used in clinical settings by healthcare professionals. Benefits include reliable central venous access for critical care and diagnostic imaging. Subject device differs from predicate only by use of TPC 980 black ink for shaft markings.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility testing per ISO 10993 and ink legibility performance testing.

Technological Characteristics

Materials: Polyethylene, ethylene-vinyl acetate, polyurethane (shaft/hub); stainless steel (needle/wire guide). Dimensions: 2.5-10 Fr, 5-26.5 cm length. Sterilization: EtO (SAL 10^-6). Non-powered, non-electrical, no software.

Indications for Use

Indicated for adult and pediatric patients requiring short-term (<30 days) central venous access for drug infusion, CVP monitoring, hyperalimentation, blood sampling, blood product delivery, or power injection of contrast media (specific models).

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• Cook Unimpregnated Central Venous Catheter (K182252)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

8/10/2026

Spectrum Vascular
Sharon Klugewicz
Sr VP, Quality & Regulatory Affairs
50 Main St.
Suite 1000
White Plains, New York 10606

Re: K260165

Trade/Device Name: Unimpregnated Central Venous Catheter
Regulation Number: 21 CFR 880.5200
Regulation Name: Intravascular Catheter
Regulatory Class: Class II
Product Code: FOZ
Dated: July 9, 2026
Received: July 9, 2026

Dear Sharon Klugewicz:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K260165 - Sharon Klugewicz

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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K260165 - Sharon Klugewicz

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assistance/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,

GANG PENG -S

Gang Peng for

David Wolloscheck

Assistant Director

DHT3C: Division of Drug Delivery and

General Hospital Devices, and

Human Factors

OHT3: Office of Gastrorenal, ObGyn,

General Hospital, and Urology Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.

K260165

Please provide the device trade name(s).

Unimpregnated Central Venous Catheter

Please provide your Indications for Use below.

The Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for:

1. Continuous or intermittent drug infusions
2. Central venous blood pressure monitoring (CVP)
3. Acute hyperalimentation
4. Blood sampling
5. Delivery of whole blood or blood products
6. Simultaneous, separate infusion of drugs for multi-lumen catheters only

The device is a short-term use catheter, intended for less than 30 days.

The Cook dilator is used for dilating puncture sites or catheter tracts.

The Unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations.

The Unimpregnated Central Venous Catheter with Power Injection is used for:

1. Continuous or intermittent drug infusions
2. Central venous blood pressure monitoring (CVP)
3. Acute hyperalimentation
4. Blood sampling
5. Delivery of whole blood or blood products
6. Simultaneous, separate infusion of drugs for multi-lumen catheters only
7. Power injection of contrast media*

*The flow rate may not exceed 3 mL/sec for 4.0 and 5.0 French catheters and 10 mL/sec for 7.0, 8.0, 9.0 and 10.0 French catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0 and 10.0 French catheters.

The device is a short-term use catheter, intended for less than 30 days.

The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter.

The Cook dilator is used for dilating puncture sites or catheter tracts.

The Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations.

Please select the types of uses (select one or both, as applicable).

☑ Prescription Use (21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

?

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510(k) Summary

Spectrum Vascular

K260165

# **1. SUBMITTER INFORMATION**

Applicant: Spectrum Vascular
Contact: Ms. Sharon Klugewicz
Phone: [phone]
Email: [e-mail]
Address: 50 Main Street, Suite 1000
White Plains, NY 10606

# **2. CORRESPONDENT INFORMATION**

Contact: Ms. Sharon Klugewicz
Title: SVP, Quality and Regulatory Affairs
Firm: Spectrum Vascular
50 Main Street, Suite 1000
White Plains, NY 10606
Phone: [phone]
Email: [e-mail]

# **3. DATE PREPARED: AUGUST 6, 2026**

# **4. DEVICE INFORMATION**

Device Name: Unimpregnated Central Venous Catheter
Common Name: Intravascular catheter
Regulation Number: 21 CFR 880.5200
Regulation Name: Intravascular catheter
Product Code: FOZ
Regulatory Class: Class II

# **5. PREDICATE DEVICE INFORMATION**

Predicate Device Name: Cook Unimpregnated Central Venous Catheter
510(k) Number: K182252
Manufacturer: Cook Incorporated

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510(k) Summary

Spectrum Vascular

K260165

## 6. DEVICE DESCRIPTION

The Unimpregnated Central Venous Catheter set includes a central venous catheter (CVC), wire guide, access needle, and syringe. The CVC is inserted into the vasculature using the Seldinger technique. The tip of the catheter is then advanced until it is above the superior vena cava-right atrium (SVC-RA) junction. The CVC is a single, double, triple, or five-lumen shaft manufactured from polyethylene, ethylene-vinyl acetate, or polyurethane tubing. The CVC is offered with and without power injection, and supplied in multiple size configurations, ranging from 2.5 to 10 French, to support a variety of vascular access needs. Single lumen CVCs are designed with a pre-molded winged hub on the proximal end. Double, triple, and five lumen CVCs are manufactured with a manifold assembly, which is designed as a winged manifold connected to extension tubes. Each extension tube has a slide clamp and is manufactured with a proximal winged hub. The wire guide is manufactured with stainless steel and may be coated with polytetrafluoroethylene (PTFE). The access needle is manufactured from stainless steel. Additional set configurations may also contain a dilator, injection caps, clamps, catheter securement device, connecting tube, and other convenience accessories.

## 7. INDICATIONS FOR USE

The Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for:

1. Continuous or intermittent drug infusions
2. Central venous blood pressure monitoring (CVP)
3. Acute hyperalimentation
4. Blood sampling
5. Delivery of whole blood or blood products
6. Simultaneous, separate infusion of drugs for multi-lumen catheters only

The device is a short-term use catheter, intended for less than 30 days.

The Cook dilator is used for dilating puncture sites or catheter tracts.

The Unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations.

The Unimpregnated Central Venous Catheter with Power Injection is used for:

1. Continuous or intermittent drug infusions
2. Central venous blood pressure monitoring (CVP)
3. Acute hyperalimentation
4. Blood sampling
5. Delivery of whole blood or blood products
6. Simultaneous, separate infusion of drugs for multi-lumen catheters only

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510(k) Summary

Spectrum Vascular

K260165

### 7. Power injection of contrast media*

*The flow rate may not exceed 3 mL/sec for 4.0 and 5.0 French catheters and 10 mL/sec for 7.0, 8.0, 9.0 and 10.0 French catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0 and 10.0 French catheters.

The device is a short-term use catheter, intended for less than 30 days.

The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter.

The Cook dilator is used for dilating puncture sites or catheter tracts.

The Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations.

## 8. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Other than the change in ink as noted in Table 1, the subject device is identical to the predicate device.

Table 1: Technological Comparison to Predicate Device

| | Predicate Device (K182252) | Subject Device (K260165) | Comparison |
| --- | --- | --- | --- |
| Regulation | 21 CFR 880.5200 | 21 CFR 880.5200 | Same |
| Product Code | FOZ | FOZ | Same |
| Classification | Class II | Class II | Same |
| Indications for Use | The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for:1. Continuous or intermittent drug infusions2. Central venous blood pressure monitoring (CVP)3. Acute hyperalimentation4. Blood sampling5. Delivery of whole blood or blood products6. Simultaneous, separate infusion of drugs for multi-lumen catheters only.The device is a short-term use catheter, intended for less than 30 days.The Cook dilator is used for dilating puncture sites or catheter tracts. | The Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for:1. Continuous or intermittent drug infusions2. Central venous blood pressure monitoring (CVP)3. Acute hyperalimentation4. Blood sampling5. Delivery of whole blood or blood products6. Simultaneous, separate infusion of drugs for multi-lumen catheters onlyThe device is a short-term use catheter, intended for less than 30 days.The Cook dilator is used for dilating puncture sites or catheter tracts. | The subject device Indications for Use is the same as the predicate device with the exception of the “Cook” name being removed in the device name. |

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510(k) Summary

Spectrum Vascular

K260165

| | Predicate Device (K182252) | Subject Device (K260165) | Comparison |
| --- | --- | --- | --- |
| | The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations. The Cook Unimpregnated Central Venous Catheter with power injection is used for: 1. Continuous or intermittent drug infusions 2. Central venous blood pressure monitoring (CVP) 3. Acute hyperalimentation 4. Blood sampling 5. Delivery of whole blood or blood products 6. Simultaneous, separate infusion of drugs for multi-lumen catheters only 7. Power injection of contrast media* *The flow rate may not exceed 3 mL/sec for 4.0 and 5.0 French catheters and 10 mL/sec for 7.0, 8.0, 9.0, and 10.0 French catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0, and 10.0 French catheters. The device is a short-term use catheter, intended for less than 30 days. The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter. The Cook dilator is used for dilating puncture sites or catheter tracts. The Cook Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations. | The Unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations. The Unimpregnated Central Venous Catheter with Power Injection is used for: 1. Continuous or intermittent drug infusions 2. Central venous blood pressure monitoring (CVP) 3. Acute hyperalimentation 4. Blood sampling 5. Delivery of whole blood or blood products 6. Simultaneous, separate infusion of drugs for multi-lumen catheters only 7. Power injection of contrast media* *The flow rate may not exceed 3 mL/sec for 4.0 and 5.0 French catheters and 10 mL/sec for 7.0, 8.0, 9.0 and 10.0 French catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0 and 10.0 French catheters. The device is a short-term use catheter, intended for less than 30 days. The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter. The Cook dilator is used for dilating puncture sites or catheter tracts. The Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations. | |
| Patient Population | Neonates/Newborns; Infants; Children; Adolescents; Adults | Neonates/Newborns; Infants; Children; Adolescents; Adults | Same |
| Catheter Placement Method | Percutaneously via Seldinger technique | Percutaneously via Seldinger technique | Same |
| Catheter Tip Target Anatomy | SVC-RA junction | SVC-RA junction | Same |

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510(k) Summary

Spectrum Vascular

K260165

| | Predicate Device (K182252) | Subject Device (K260165) | Comparison |
| --- | --- | --- | --- |
| Catheter tip Location Confirmation Method | ECG/Ultrasound/Fluoroscopy | ECG/Ultrasound/Fluoroscopy | Same |
| Power Injectable Catheter Configurations (7-10Fr) | Dual Lumen: 8 FrTriple Lumen: 7, 9 FrFive-Lumen: 10 Fr | Dual Lumen: 8 FrTriple Lumen: 7, 9 FrFive-Lumen: 10 Fr | Same |
| Upper Pressure Limit for Power Injection (7-10Fr) | 325 psi | 325 psi | Same |
| Power Injectable Catheter Configurations (4-5 Fr) | Dual Lumen: 4, 5 FrTriple Lumen: 5 Fr | Dual Lumen: 4, 5 FrTriple Lumen: 5 Fr | Same |
| Upper Pressure Limit for Power Injection (4-5 Fr) | 250 psi | 250 psi | Same |
| Catheter Shaft Material | PolyethyleneEthylene-Vinyl AcetatePolyurethane | PolyethyleneEthylene-Vinyl AcetatePolyurethane | Same |
| Catheter Shaft Marking Ink | UVA Ink (Color #1 Black) | UVA Ink (TPC 980 Black Ink) | Different: Biocompatibility testing was conducted in accordance with ISO 10993 and supports a determination that the new ink is biocompatible and thus the catheters are substantially equivalent.An additional ink legibility performance test was conducted to demonstrate that the device meets its design requirements and performs as intended. |
| Catheter Hub Material | PolyethylenePolyurethane | PolyethylenePolyurethane | Same |
| Number of Catheter Lumens | 1, 2, 3, 5 | 1, 2, 3, 5 | Same |
| Catheter Outer Diameter (Fr) | Single – 2.5, 3, 4, 5, 6, 6.3 FrDual – 4, 5, 7.5, 8 FrTriple – 5, 7, 9 FrFive – 10 Fr | Single – 2.5, 3, 4, 5, 6, 6.3 FrDual – 4, 5, 7.5, 8 FrTriple – 5, 7, 9 FrFive – 10 Fr | Same |
| Catheter Length | 5 to 26.5 cm | 5 to 26.5 cm | Same |
| Packaging | PETG Tray w/ Tyvek Lidstock | PETG Tray w/ Tyvek Lidstock | Same |
| Single Use? | Yes | Yes | Same |
| Sterilization Method | EtO | EtO | Same |
| Sterility Assurance Level | \( 10^{-6} \) | \( 10^{-6} \) | Same |

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510(k) Summary

Spectrum Vascular

K260165

# 9. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

# Biocompatibility Testing

The catheter of the subject device is identical to the Unimpregnated Central Venous Catheter cleared in K182252 with the exclusion of the marker ink. Additional biocompatibility testing on the subject device was conducted in accordance with the ISO 10993 series.

# Electrical Safety

Not applicable. The subject device contains no electrical components, generates no electrical emissions, and uses no electrical energy of any type.

# Electromagnetic Compatibility (EMC)

Not applicable. The subject device contains no electrical components, generates no electrical emissions, and uses no electrical energy of any type.

# Software

Not applicable. The subject device contains no software.

# Performance Testing

An additional ink legibility performance test was conducted to demonstrate that the device meets its design requirements and performs as intended.

# 10. CONCLUSION

The results of the performance testing described above demonstrate that the Unimpregnated Central Venous Catheter performs equivalently as compared to the predicate device and supports a determination of substantial equivalence.

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