PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,

K083784 · Vascular Solutions, Inc. · QEZ · Mar 30, 2009 · Cardiovascular

Device Facts

• Record ID: K083784
• Device Name: PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,
• Applicant: Vascular Solutions, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Mar 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PRONTO extraction catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The SKYWAY support catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The SKYWAY OTW also may be used to subselectively infuse/deliver therapeutic agents. The TWIN-PASS dual access catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.

Device Story

Catheter family includes extraction (Pronto V3/LP) and support/access (Skyway RX/OTW, Twin-Pass) devices. Extraction catheters use dual-lumen design; larger lumen allows thrombus aspiration via syringe/stopcock; smaller lumen accommodates guidewires. Support/access catheters provide guidewire support; facilitate guidewire exchange; Twin-Pass allows dual-guidewire procedures; Skyway OTW/Twin-Pass allow subselective infusion. All devices are hydrophilically coated. Used in interventional procedures by physicians to navigate coronary/peripheral vasculature. Pronto catheters include 70um filter basket for thrombus analysis. Stiffening mandrels/stylets included for delivery support. Clinical benefit: improved vessel access, thrombus removal, and therapeutic delivery.

Clinical Evidence

Bench testing only. Verification testing and biomaterial assessments performed to qualify hydrophilic coating modifications.

Technological Characteristics

Dual-lumen (Pronto/Twin-Pass) or single-lumen (Skyway) catheters; hydrophilically coated; compatible with 0.014" guidewires; 6F guide catheter compatible; includes accessories (syringes, stopcocks, 70um filter basket, stiffening mandrels/stylets).

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from coronary and peripheral vessels (Pronto V3/LP); access to coronary/arterial vasculature, guidewire placement/exchange, and subselective infusion of therapeutic/diagnostic agents (Skyway/Twin-Pass).

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• Pronto V3 extraction catheter (K063371)
• Pronto LP extraction catheter (K072810)
• Skyway RX support catheter (K060327)
• Skyway OTW support catheter (K060327)
• Twin-Pass dual access catheter (K060327)

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). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

May 20, 2021

Vascular Solutions, Inc. Charmaine Sutton Acting VP Of Regulatory 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K083784

Trade/Device Name: Pronto V3 Extraction Center, Pronto LP Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: OEZ

Dear Charmaine Sutton:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 30, 2009. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, [phone]. Gregory. Oconnell(@FDA.HHS.gov.

Sincerely,

Image /page/0/Picture/9 description: The image shows a digital signature. On the left side, the name "Gregory W. O'connell -S" is written in a large font. On the right side, the text "Digitally signed by Gregory W. O'connell -S Date: 2021.05.20 09:35:42 -04'00'" is written in a smaller font. The signature indicates that the document was signed by Gregory W. O'connell on May 20, 2021, at 09:35:42 with a time zone offset of -04'00'.

Gregory O'Connell 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

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Public Health Service

MAR 3 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Solutions, Inc. c/o Ms. Charmaine Sutton, RAC 6464 Sycamore Court Minneapolis, MN 55369

Re: K083784

> Trade/Device Name: Pronto V3 extraction catheter, Pronto LP extraction catheter, Skyway RX support catheter, Skyway OTW support catheter, and Twin-Pass dual access catheter

Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE, DQY Dated: March 16, 2009 Received: March 17, 2009

Dear Ms. Sutton:

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 (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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

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Page 2 - Ms. Charmaine Sutton

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. Turner

Image /page/2/Picture/5 description: The image shows a handwritten symbol or character. It appears to be a stylized or cursive form, possibly resembling a letter or a unique mark. The symbol is drawn with thick, dark lines, suggesting it was created with a pen or marker. The overall impression is that of a signature, initial, or abstract design.

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ _ _ 003789

Skyway® OTW support catheter Device Name: Skyway® RX support catheter

Indications for Use:

The SKYWAY support catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The SKYWAY OTW also may be used to subselectively infuse/deliver therapeutic agents.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Posted November 13, 2003)

3

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Twin-Pass® dual access catheter

Indications for Use:

The TWIN-PASS dual access catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infusc/deliver diagnostic or therapeutic agents.

Prescription Use X (Part 21 CFR 801 Subpart D)

ﻴﺔ

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Posted November 13, 2003)

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510(k) Number (if known): K083784

.

Pronto® V3 extraction catheter Device Name: Pronto® LP extraction catheter

Indications for Use:

The PRONTO extraction catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

. При 1910 года продательно продобродности при полности и моремника по примество полнения по странция по подательности по полнения по полнения по подательные поведника с

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

5

(Posted November 13, 2003)

R.L. Jones

Division Sign-Off) avision of Cardiovascular Devices

510(k) Number_KO83784

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Vascular Solutions, Inc.

Traditional 510(k) Premarket Notification Hydrophilic Coating Modification for Pronto V3, Pronto LP, Skyway and Twin-Pass Catheters

1683784

#### 3 510(k) Summary

Date Prepared: December 18, 2008

## Submitter's Name / Contact Person

#### Manufacturer

Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812

## Contact Person

Charmaine Sutton, RAC Acting VP of Regulatory Tel: [phone] (direct); Fax: [phone] Email: [e-mail]

| Common Name<br>(Classification) | Trade Name | Predicate Device |
|-----------------------------------------------|---------------------------------|----------------------------------------|
| Embolectomy<br>catheter<br>(21 CFR 870.5150) | Pronto® V3 extraction catheter | K063371 Pronto V3 extraction catheter |
| | Pronto® LP extraction catheter | K072810 Pronto LP extraction catheter |
| Percutaneous<br>catheter<br>(21 CFR 870.1250) | Skyway® RX support catheter | K060327 Skyway RX support catheter |
| | Skyway® OTW support catheter | K060327 Skyway OTW support catheter |
| | Twin-Pass® dual access catheter | K060327 Twin-Pass dual access catheter |

#### General Information

## Device Description

The Pronto V3 extraction catheter is a dual lumen, hydrophilically coated, rapid exchange catheter with related accessories. The smaller wire lumen of the catheter is able to accommodate guidewires that are ≤ 0.014"/0.36mm in diameter. The larger extraction lumen allows for the removal of thrombus by use of the included syringe through the extension line and stopcock. The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen to facilitate advancement of the catheter into the blood vessel and maximize extraction of thrombus through the extraction lumen. The proximal end of the catheter has a standard luer adapter that attaches to the included extension line, stopcock and syringes. The catheter has a working length of 140cm and is compatible with standard 6F guide catheters. A 70um filter basket is included for assistance in filtering the blood removed during the procedure for laboratory analysis of any thrombosis.

The Pronto LP extraction catheter is a dual lumen, hydrophilically coated rapid exchange catheter with related accessories. The smaller wire lumen of the catheter is able to accommodate guidewires that are <0.014"/0.36mm in diameter. The larger extraction lumen comes pre-loaded with a stylet that resists kinking during delivery but is removed to allow for the removal of

MAR 3 0 2009

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thrombus by aspiration. The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen to facilitate advancement of the catheter into the blood vessel and maximize extraction of thrombus the extraction lumen. The proximal end of the catheter has a Yadapter hub containing a self-sealing stylet port, as well as a side-port for the attachment of the included extension line. The catheter has a working length of 137cm and is compatible with standard 6F guide catheters. A 70um filter basket is included for assistance in filtering the blood removed during the procedure for laboratory analysis of any thrombosis.

The Skyway OTW (over-the-wire) and Skyway RX (rapid exchange) support catheters are single lumen, hydrophilically coated catheters designed for use in the arterial vasculature. The catheters provide support for 0.014"/0.36mm guidewires during interventional procedures, and allow for the exchange of one distally located guidewire for another one while maintaining access to distal vasculature. The Skyway RX has a rapid exchange port that allows for the insertion of the catheter over a short guidewire; a stiffening mandrel provides support and pushability during catheter insertion.

The Twin-Pass dual access catheter is a hydrophilically coated, dual lumen catheter designed for use in the arterial vasculature. The catheter provides support for 0.014"/0.36mm guidewires during interventional procedures, and the dual lumen design allows for the delivery of a second guidewire into distal vasculature while leaving the initial guidewire in place. A stiffening mandrel provides support and pushability during catheter insertion.

#### Intended Use / Indications

The PRONTO extraction catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

The SKYWAY support catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The SKY WAY OTW also may be used to subselectively infuse/deliver therapeutic agents.

The TWIN-PASS dual access catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.

### Substantial Equivalence and Summary of Studies

Pronto, Skyway and Twin-Pass catheters are substantially equivalent in intended use / indications and design to their predicate devices. Hydrophilic coating design differences have been qualified through biomaterial assessments and verification testing, the results of which did not raise any new safety or performance questions.

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

MAR 3 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Solutions, Inc. c/o Ms. Charmaine Sutton, RAC 6464 Sycamore Court Minneapolis, MN 55369

Re: K083784

> Trade/Device Name: Pronto V3 extraction catheter, Pronto LP extraction catheter, Skyway RX support catheter, Skyway OTW support catheter, and Twin-Pass dual access catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE, DQY Dated: March 16, 2009 Received: March 17, 2009

Dear Ms. Sutton:

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 (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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

{9}------------------------------------------------

Page 2 - Ms. Charmaine Sutton

CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Drma. R. Wulner

Image /page/9/Picture/5 description: The image shows a stylized, handwritten letter 'W'. The letter is formed with curved lines, giving it a flowing appearance. The base of the 'W' has a slight slant, and the overall design is simple and elegant.

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{10}------------------------------------------------

510(k) Number (if known): KO83784

Skyway® OTW support catheter Device Name: Skyway® RX support catheter

Indications for Use:

The SKYWAY support catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The SK YWA Y OTW also may be used to subselectively infuse/deliver therapeutic agents.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Posted November 13, 2003)

{11}------------------------------------------------

510(k) Number (if known):

Device Name: Twin-Pass® dual access catheter

Indications for Use:

The TWIN-PASS dual access catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Posted November 13, 2003).

{12}------------------------------------------------

510(k) Number (if known): K083784

Pronto® V3 extraction catheter Device Name: Pronto® LP extraction catheter

Indications for Use:

The PRONTO extraction catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Posted November 13, 2003)

ima R.L. Jones

Division Sign-Off) Ivision of Cardiovascular Devices

510(k) Number_KO83784