510(k) Report

510(k) · Cleared

Cleared

Cvsi Peripheral Balloon Catheter; Cvsi Inflater

K022061510(k) TraditionalCleared Sep 20, 200287-day reviewClass II21 CFR 870.1250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cryo Vascular Systems, Inc. · DQY Catheter, Percutaneous

Cleared on Sep 20, 2002 as substantially equivalent to K944016 (Cardiovascular Dynamics, Inc., 1994) and 3 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1991. 9 later devices descend from it.

Decided
Sep 20, 2002
Review
87 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K904275 (1991). 5 ancestors in all, the oldest K896849 (1990). 9 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1994: 1 other ancestor1990: 1 other ancestor2004: 2 descendants cleared2005: 2 descendants cleared2003: 1 descendant cleared2007: 1 descendant cleared2015: 1 descendant cleared2006: 1 descendant cleared2024: 1 descendant clearedK904275 · Morse Balloon Inflation Device · North American Instrument Corp. · 1991K953676 · Breeze Digital Inflation Device · Namic · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K953676 · Breeze Digital Inflation Device · Namic · 1996K904275 · Morse Balloon Inflation Device · North American Instrument Corp. · 19910
  1. Root · 2 generations backK904275 Morse Balloon Inflation DeviceNorth American Instrument Corp. · 1991
  2. 1 generation backK953676 Breeze Digital Inflation DeviceNamic · 1996
  3. This deviceK022061 Cvsi Peripheral Balloon Catheter; Cvsi InflaterCryo Vascular Systems, Inc. · 2002
  4. Descendant · cites it directly · 6 of its ownK040155 Peripheral Cutting BalloonBoston Scientific Corp · 2004
  5. Descendant · cites it directly · 5 of its ownK051254 Peripheral Cutting BalloonBoston Scientific Ivt · 2005
  6. Descendant · cites it directly · 5 of its ownK041993 2 CM Peripheral Cutting BaloonBoston Scientific Ivt · 2004
  7. Descendant · 2 generations on · 4 of its ownK052038 Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery…Boston Scientific Corporation · 2005 · Recalled
  8. Descendant · 3 generations on · 3 of its ownK062387 Small Peripheral Cutting Ballon, Monorail Delivery SystemBoston Scientific · 2006

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22005: 22006: 12007: 12015: 12024: 1
2003high 2 (2004) · low 0 (2008)2026

Most influential descendants

Showing 5 of 9 · See all
  • K040155Peripheral Cutting BalloonBoston Scientific Corp · 2004 · cites it directly6descendants
  • K051254Peripheral Cutting BalloonBoston Scientific Ivt · 2005 · cites it directly5descendants
  • K0419932 CM Peripheral Cutting BaloonBoston Scientific Ivt · 2004 · cites it directly5descendants
  • K052038Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery SystemBoston Scientific Corporation · 2005 · 2 generations on4descendants
  • K062387Small Peripheral Cutting Ballon, Monorail Delivery SystemBoston Scientific · 2006 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K904275Morse Balloon Inflation DeviceNorth American Instrument Corp.1991—
−1K953676Breeze Digital Inflation DeviceNamic1996—
0 (this device)K022061Cvsi Peripheral Balloon Catheter; Cvsi InflaterCryo Vascular Systems, Inc.2002—
+1K040155Peripheral Cutting BalloonBoston Scientific Corp2004—
+1K051254Peripheral Cutting BalloonBoston Scientific Ivt2005—
+1K0419932 CM Peripheral Cutting BaloonBoston Scientific Ivt2004—
+2K052038Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery SystemBoston Scientific Corporation20052
+3K062387Small Peripheral Cutting Ballon, Monorail Delivery SystemBoston Scientific2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199410
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200520
200610
200710
201510
202410
FIG. 1 — Lineage of K022061, 1991–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQY device

  1. #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K944016Focus Balloon Dilatation Catheter
Summary page 1
…Injector and Syringe, Angiographic (21 CFR 3 870.1650) PREDICATE DEVICES (1) FOCUS PV Balloon Dilatation Catheter by Cardiovascular Dynamics (K944016) (2) OPTA LP PTA Catheter Cordis/A Johnson & Johnson Company (K971448) (3) ACS 20/20 Indeflator by Guidant/Advanced Cardi…
Cardiovascular Dynamics, Inc.1994—
*K971448Cordis Opta LP Pta Balloon Catheter
Summary page 1
…0) PREDICATE DEVICES (1) FOCUS PV Balloon Dilatation Catheter by Cardiovascular Dynamics (K944016) (2) OPTA LP PTA Catheter Cordis/A Johnson & Johnson Company (K971448) (3) ACS 20/20 Indeflator by Guidant/Advanced Cardiovascular Systems, Inc. (K896849) (4) Breeze Digital Balloon Inflation…
Cordis Corp.1997—
*K896849Acs Indeflator XX
Summary page 1
…namics (K944016) (2) OPTA LP PTA Catheter Cordis/A Johnson & Johnson Company (K971448) (3) ACS 20/20 Indeflator by Guidant/Advanced Cardiovascular Systems, Inc. (K896849) (4) Breeze Digital Balloon Inflation Device by NAMIC USA (K953676) INTENDED USE The CVSiTMPeripheral Balloon Catheter and…
Advanced Cardiovascular Systems, Inc.1990—
*K953676Breeze Digital Inflation Device
Summary page 1
…n Company (K971448) (3) ACS 20/20 Indeflator by Guidant/Advanced Cardiovascular Systems, Inc. (K896849) (4) Breeze Digital Balloon Inflation Device by NAMIC USA (K953676) INTENDED USE The CVSiTMPeripheral Balloon Catheter and the CVSiTMInflator are indicated for percutaneous, transluminal angiopl…
Namic1996—

Also cleared against K944016: 2 other devices →

What descends from it? (9)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040155Peripheral Cutting BalloonBoston Scientific Corp20046
K051254Peripheral Cutting BalloonBoston Scientific Ivt20055
K0419932 CM Peripheral Cutting BaloonBoston Scientific Ivt20045
K023463Cvsi Peripheral Balloon Catheter; Cvsi Catheter Inflation UnitCryo Vascular Systems, Inc.20030

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K040155 (Boston Scientific Corp, 2004) has gone furthest, with 6 descendants of its own.
  • 2 other devices also cite its predicate K944016.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

The CVSiTMPeripheral Balloon Catheter and the CVSiTM Inflator are indicated for percutaneous, transluminal angioplasty of stenotic lesions in the superficial femoral and popliteal arteries. The CVSiTMPeripheral Balloon Catheter System is not indicated for use in other vasculature, including coronary arteries, carotid arteries, synthetic vascular grafts, and vein grafts. The CVSiTMPeripheral Balloon Catheter System is not indicated for stent delivery or stent expansion.

Indications for use as stated in the FDA summary.

Also cleared against K944016

2 other devices cite the same predicate.

  • K971577Focus-PV Balloon Dilatation CatheterCardiovascular Dynamics, Inc. · 1997
  • K963688Focus PV Balloon Dilatation CatheterCardiovascular Dynamics, Inc. · 1997

More from Cryo Vascular Systems, Inc.

7 FDA decisions under this applicant name. See the company

  • K051916Polar Cath Peripheral Dilatation SystemCryo Vascular Systems, Inc. · 2005
  • K042230Polarcath Peripheral Balloon Catheter SystemCryo Vascular Systems, Inc. · 2004
  • K042541Modification to Polarcath Peripheral Dilatation SystemCryo Vascular Systems, Inc. · 2004
  • K033622Polarcath Peripheral Dilatation SystemCryo Vascular Systems, Inc. · 2004
  • K030742Polarcath Peripheral Balloon Catheter SystemCryo Vascular Systems, Inc. · 2003

Recent decisions in DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K022061 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022061: Cvsi Peripheral Balloon Catheter; Cvsi Inflater.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022061

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026