510(k) · Cleared

Cleared

Attain 6215 Venogram Balloon Catheter

K012225510(k) TraditionalCleared Aug 28, 200143-day reviewClass II21 CFR 870.1240

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

Medtronic Vascular · DYG Catheter, Flow Directed

Cleared on Aug 28, 2001 as substantially equivalent to K822806 (Nova Medical Specialties, 1982) and 2 other predicates after a 43-day review. Its family tree reaches back 1 generation to 1982. 1 later device descends from it.

Decided: Aug 28, 2001
Review: 43 days
Class: Class II
Product code: DYG
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K822806 (1982). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK822806 Balloon Wedge Pressure, AngiographicNova Medical Specialties · 1982 · Recalled
This deviceK012225 Attain 6215 Venogram Balloon CatheterMedtronic Vascular · 2001
Descendant · cites it directly · 0 of its ownK121219 Attain Clarity 6225 Venogram Balloon CatheterMedtronic, Inc. · 2012

Most influential descendants

Showing 1 of 1 · See all

K121219Attain Clarity 6225 Venogram Balloon CatheterMedtronic, Inc. · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K822806	Balloon Wedge Pressure, Angiographic	Nova Medical Specialties	1982	20
0 (this device)	K012225	Attain 6215 Venogram Balloon Catheter	Medtronic Vascular	2001	—
+1	K121219	Attain Clarity 6225 Venogram Balloon Catheter	Medtronic, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K012225, 1982–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DYG? 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 DYG device

#1 K242451 HemoSphere Alta Advanced Monitoring Platform…score 24.2 · 39 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K822806	Balloon Wedge Pressure, Angiographic Summary page 2 …theter is outlined in the following table. Predicate Device Predicate Device Predicate 510(k) Manufacturer Balloon Wedge Pressure, Angiographic B. Braun Medical, Inc.* K822806 Allentown, PA 18103 cleared 11/1/82 Accent DG ™ Balloon Angioplasty Cook, Inc K900677 Catheter Bloomington, IN 47402 cleared 02/…	Nova Medical Specialties	1982	20
*	K900677	Accent DG (TM) Balloon Angioplasty Catheter Summary page 2 …510(k) Manufacturer Balloon Wedge Pressure, Angiographic B. Braun Medical, Inc.* K822806 Allentown, PA 18103 cleared 11/1/82 Accent DG ™ Balloon Angioplasty Cook, Inc K900677 Catheter Bloomington, IN 47402 cleared 02/22/91 Vueport ™ Coronary Sinus Balloon Cardima, Inc K973298 Occlusion Guiding Catheter…	Cook, Inc.	1991	—
*	K973298	Cardima Vueport Coronary Sinus Balloon Occlusion Guiding Catheter Summary page 2 …A 18103 cleared 11/1/82 Accent DG ™ Balloon Angioplasty Cook, Inc K900677 Catheter Bloomington, IN 47402 cleared 02/22/91 Vueport ™ Coronary Sinus Balloon Cardima, Inc K973298 Occlusion Guiding Catheter Freemont, CA 94538 cleared 06/26/98 Summary of Studies Compatibility testing and incoming inspection…	Cardima, Inc.	1998	—

Also cleared against K822806: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K121219	Attain Clarity 6225 Venogram Balloon Catheter	Medtronic, Inc.	2012	0

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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K121219 (Medtronic, Inc., 2012) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K822806.

How does its category compare?

All DYG devices

DYG Catheter, Flow Directed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYG

3in 2024

2007high 3 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYG

188in 2024

2007high 188 (2024)2026

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

Recalls per year · DYG

2in 2019

2007high 4 (2018) · low 0 (2008)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · DYG

268in 2025

2007high 400 (2008) · low 97 (2021)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	1	168
2008	1	—	0	400
2009	0	—	3	145
2010	0	—	0	147
2011	1	—	0	249
2012	0	—	0	221
2013	0	—	1	149
2014	0	—	0	178
2015	0	—	0	163
2016	1	—	0	154
2017	0	—	0	115
2018	0	—	4 (4)	133
2019	0	—	2	144
2020	1	—	0	104
2021	0	—	0	97
2022	1	—	0	130
2023	1	—	0	229
2024	3	188	0	226
2025	0	—	0	268
2026	0	—	2	—

What is it indicated for?

The Attain 6215 Venogram balloon catheter is indicated for

use within the coronary sinus; it is intended for infusing contrast

solutions into the coronary vasculature for venogram imaging.

The Attain 6215 Venogram balloon catheter is intended for

single use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012225 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012225: Attain 6215 Venogram Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012225

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026