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FDA 510(k)

BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE

K-Number: K990284 · 2001-02-01

ApplicantBaylis Medical Co., Inc.
Decision Date2001-02-01
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Co., Inc.. It received FDA 510(k) clearance on 2001-02-01 under 510(k) number K990284. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE?

BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE is a medical device that received FDA 510(k) clearance on 2001-02-01. The listed applicant is Baylis Medical Co., Inc.. The 510(k) number is K990284.

When did BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE receive FDA 510(k) clearance?

BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE received FDA 510(k) clearance on 2001-02-01, under 510(k) number K990284.

Who is the listed applicant for BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE?

The FDA 510(k) record lists Baylis Medical Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE?

The FDA product code for BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE is DXF.

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Other records listing Baylis Medical Co., Inc. as applicant

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Related Devices (Code: DXF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261745LightningWire Transseptal Puncture System (TPS)ElectroWire MedicalK253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)Pressure Products Medical Device Manufacturing, LLCK260292HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)Atraverse MedicalK252419HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)Atraverse Medical, Inc.K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)Circa Scientific, Inc.K243193Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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