ClearanceBrief
Panels › Cardiovascular › Product code DTL · Class 2

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Regulation 870.4290

0510(k)s in 12 months (137 all time)
5recalls in 12 months (59 all time)
46recalls that name a 510(k)
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Top companies in DTL

DateFirm and productCodeLinked 510(k)
May 8, 2026Medline Industries, LP
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Open, Classified
DTLK782095
May 8, 2026Medline Industries, LP
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Open, Classified
DTLK782095
May 8, 2026Medline Industries, LP
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Open, Classified
DTLK782095
Apr 7, 2026Medline Industries, LP
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2
Open, Classified
DTLNone listed
Nov 17, 2025Merit Medical Systems, Inc.
PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP80
Open, Classified
DTLNone listed
Sep 11, 2025Merit Medical Systems, Inc.
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis duri
Open, Classified
DTLNone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED, Pack Number 132701; 3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ; 4) K
Open, Classified
DTLNone listed
May 16, 2023Boston Scientific Corporation
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
Open, Classified
DTLK172453
May 16, 2023Boston Scientific Corporation
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Open, Classified
DTLK172453
Mar 1, 2022Merit Medical Systems, Inc.
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05
Open, Classified
DTLNone listed
Mar 1, 2022Merit Medical Systems, Inc.
Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-021
Open, Classified
DTLNone listed
Aug 6, 2021Medline Industries Inc
NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003,
Terminated
DTLK782095
K842829
Aug 6, 2021Medline Industries Inc
NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (2) NAMIC Angiographic MAN
Terminated
DTLK782095
K842829
Apr 24, 2020LivaNova USA Inc.
1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
Terminated
DTLNone listed
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 / 00803622123184
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153
Terminated
DTLK833322
Nov 18, 2019LivaNova USA Inc.
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Terminated
DTLK833322
May 9, 2018Cook Inc.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The conne
Terminated
DTLNone listed
May 9, 2018Cook Inc.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The conne
Terminated
DTLNone listed
May 9, 2018Cook Inc.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connec
Terminated
DTLNone listed
May 9, 2018Cook Inc.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connec
Terminated
DTLNone listed
May 9, 2018Cook Inc.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The co
Terminated
DTLNone listed
May 9, 2018Cook Inc.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connec
Terminated
DTLNone listed
Jul 10, 2017Medtronic Perfusion Systems
DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate
Terminated
DTLK900994
Jul 10, 2017Medtronic Perfusion Systems
DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
Terminated
DTLK790564
Jun 27, 2017Terumo Cardiovascular Systems Corporation
Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156
Terminated
DTLK820297
Jun 27, 2017Terumo Cardiovascular Systems Corporation
TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
Terminated
DTLK820297
Apr 7, 2016Vascular Solutions, Inc.
Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product Usage: The Guardian hemostasis valves
Terminated
DTLK122301
Jun 23, 2015Terumo Cardiovascular Systems Corp
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
Terminated
DTLK820297
Nov 6, 2014Dokitz NovoSci
Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014
Terminated
DTLK801404
Mar 20, 2013Vascular Solutions, Inc.
Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, F
Terminated
DTLK092711
K101113 +1
Oct 25, 2012Sorin Group USA, Inc.
Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 1219200107, Exp. Dates: 3/31/14, 7/31/14, 2/28/15, 3/31/15, 7/3
Terminated
DTLK833322
Oct 25, 2012Sorin Group USA, Inc.
Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15. Product Usage: The conne
Terminated
DTLK833322

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